Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Congressional research reportJan 10, 2014

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Food Fraud and “Economically Motivated

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Specialist in Agricultural Policy

January 10, 2014

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R43358

Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Summary

Food fraud, or the act of defrauding buyers of food or ingredients for economic gain—whether

they be consumers or food manufacturers, retailers, and importers—has vexed the food industry

throughout history. Some of the earliest reported cases of food fraud, dating back thousands of

years, involved olive oil, tea, wine, and spices. These products continue to be associated with

fraud, along with some other foods. Although the vast majority of fraud incidents do not pose a

public health risk, some cases have resulted in actual or potential public health risks. Perhaps the

most high-profile case has involved the addition of melamine to high-protein feed and milk-based

products to artificially inflate protein values in products that may have been diluted. In 2007, pet

food adulterated with melamine reportedly killed a large number of dogs and cats in the United

States, followed by reports that melamine-contaminated baby formula had sickened thousands of

Chinese children. Fraud was also a motive behind Peanut Corporation of America’s actions in

connection with the Salmonella outbreak in 2009, which killed 9 people and sickened 700.

Reports also indicate that fish and seafood fraud is widespread, consisting mostly of a lowervalued species, which may be associated with some types of food poisoning or allergens,

mislabeled as a higher-value species. Other types of foods associated with fraud include honey,

meat and grain-based foods, fruit juices, organic foods, coffee, and some highly processed foods.

It is not known conclusively how widespread food fraud is in the United States or worldwide. In

part, this is because those who commit food fraud want to avoid detection and do not necessarily

intend to cause physical harm. Most incidents go undetected since they usually do not result in a

food safety risk and consumers often do not notice a quality problem. Although the full scale of

food fraud is not known, the number of documented incidents may be a small fraction of the true

number of incidents. The Grocery Manufacturers Association estimates that fraud may cost the

global food industry between $10 billion and $15 billion per year, affecting approximately 10%

of all commercially sold food products. Fraud resulting in a food safety or public health risk event

could have significant financial or public relations consequences for a food industry or company.

There is no statutory definition of food fraud or “economically motivated adulteration” (EMA) of

foods or food ingredients in the United States. However, as part of a 2009 public meeting, the

Food and Drug Administration (FDA) adopted a working definition, defining EMA as the

“fraudulent, intentional substitution or addition of a substance in a product for the purpose of

increasing the apparent value of the product or reducing the cost of its production, i.e., for

economic gain.” Efforts are ongoing to compile and capture current and historical data on food

fraud and EMA incidents through the creation of databases and repositories.

Over the years, Congress has introduced a number of bills intended to address concerns about

food fraud for a particular food or food ingredient. Such legislation has not addressed food fraud

in a comprehensive manner. However, although no single federal agency or U.S. law directly

addresses food fraud, a number of existing laws and statutes already provide the authority for

various federal agencies to address fraud. Currently, food fraud is broadly addressed through

various food safety, food defense, and food quality authorities as well as border protection and

import authorities across a number of federal agencies. FDA and the U.S. Department of

Agriculture are the principle agencies that are working to protect the food supply from food

safety risks—both unintentionally and intentionally introduced contamination—in conjunction

with border protection and enforcement activities by the U.S. Department of Homeland Security.

Other agencies also play a role.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Contents

Background ...................................................................................................................................... 1

Existing Definitions ................................................................................................................... 5

Risks to Food Protection ........................................................................................................... 7

Available Data and Information Repositories ................................................................................ 10

Review of Available Database Information ............................................................................. 10

USP Food Fraud Database ................................................................................................ 11

NCFPD EMA Incident Database....................................................................................... 12

Leading Reported Types of Fraud ........................................................................................... 13

USP Food Fraud Database ................................................................................................ 14

NCFPD EMA Incident Database....................................................................................... 17

Differences in Product Ranking among Databases ................................................................. 20

Federal Activities Involving Food Fraud ....................................................................................... 22

HHS, Food and Drug Administration ...................................................................................... 24

Food Safety Authorities..................................................................................................... 24

Potential Role of the Food Safety Modernization Act ...................................................... 28

Import Authorities ............................................................................................................. 30

USDA, Food Safety and Inspection Service ........................................................................... 32

Food Safety Authorities..................................................................................................... 32

Import Authorities ............................................................................................................. 35

DHS, Customs and Border Protection ..................................................................................... 35

Other Federal Food Quality or Food Safety Programs ............................................................ 36

USDA, Agricultural Marketing Service ............................................................................ 37

NOAA, National Marine Fisheries Service ....................................................................... 38

Congressional Actions Involving Food Fraud ............................................................................... 39

Figures

Figure 1. Food Protection Risk Matrix ............................................................................................ 9

Figure 2. Leading Reported Types of Fraud, USP Scholarly Records (1980-2010) ...................... 15

Figure 3. Leading Reported Types of Fraud, USP Media Records (1980-2010) ........................... 15

Figure 4. Leading Reported Types of Fraud, USP Scholarly Records (1980-2012) ...................... 16

Figure 5. Leading EMA Incidents by Food Ingredient Category (1980 to date) ........................... 18

Figure 6. Leading EMA Incidents by Type of Adulteration (1980 to date) ................................... 19

Figure 7. Leading EMA Incidents by Location Produced (1980 to date) ...................................... 20

Tables

Table 1. Food Protection Risk: Examples, Cause and Effects ......................................................... 9

Table 2. Scope of USP Food Fraud Database ................................................................................ 14

Table 3. Leading Reported Types of Food Fraud, Differing Compilations ................................... 21

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Table 4. Registered Food Facilities, FY2004-FY2012 ................................................................. 27

Contacts

Author Contact Information........................................................................................................... 40

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Background

Food fraud, or the act of defrauding buyers of food and food ingredients for economic gain—

whether they be consumers or food manufacturers, retailers, and importers—has vexed the food

industry throughout history. Some of the earliest reported cases of food fraud, dating back

thousands of years, involved olive oil, wine, spices, and tea.1 These same products continue to be

associated with fraud, along with a range of other products. Overall, foods and food ingredients

commonly associated with food fraud include olive oil, fish, honey, milk and dairy products, meat

products, grain-based foods, fruit juices, wine and alcoholic beverages, organic foods, spices,

coffee, and tea, and some highly processed foods. It is not known conclusively how widespread

food fraud is in the United States or worldwide. In part, this is because those who commit fraud

do not intend to cause physical harm and want to avoid detection. Most incidents go undetected

since they usually do not result in a food safety risk and consumers often do not notice a quality

problem. Moreover, as the motivation to commit fraud is illicit monetary gain, the type of food

that might be or become adulterated is a secondary consideration (i.e., it could be any type of

food or food ingredient); rather, it is the opportunity or feasibility of committing fraud that

generally triggers the fraud.2

Although the vast majority of food fraud incidents do not pose a public health risk, there have

been fraud cases that have resulted in actual or potential public health risks. Perhaps the most

widely cited, high-profile cases have involved the addition of melamine to high-protein feed and

milk-based products to artificially inflate protein values in products that may have been diluted.

For example, in 2007, evidence emerged that adulterated pet food ingredients from China had

caused the deaths of a large number of dogs and cats in the United States.3 This was followed by

reports that melamine-contaminated baby formula had sickened an estimated 300,000 Chinese

children, killing a reported 6 infants.4 Evidence now suggests that safety risks associated with

melamine-tainted feed date back to 2003, and that melamine was first reported to be added to

artificially increase protein content in feed as far back as 1982.5

Reports also indicate fish and seafood fraud may be widespread in some markets, consisting

mostly of the mislabeling or substitution of a higher-valued species with something different from

and inferior to the expected species, possibly with a fish species which could be associated with

some types of food poisoning or exposure to certain allergens.6 Similarly, substitution of olive oil

with other types of seed, legume, or nut oils could have unintended consequences, if consumed by

those with certain food allergies.

1

See, for example, B. Wilson, Swindled: From Poison Sweets to Counterfeit Coffee—The Dark History of Food Fraud,

John Murray (Publishers), 2008; T. Mueller, Extra Virginity: The Sublime and Scandalous World of Olive Oil, W. W.

Norton & Company, 2011; and S. Foster, “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs,”

HerbalGram, Issue 92 (pp. 42-57), 2011, American Botanical Council.

2

CRS communication with researchers at the United States Pharmacopeial Convention (USP), December 23, 2013.

3

For other background information, see CRS Report RL34080, Food and Agricultural Imports from China.

4

H. Bottemiller, “Chinese Authorities Seize Melamine-tainted Dairy,” Food Safety News, April 29, 2011.

5

J. Moore, “The USP Food Fraud Database, and Beyond” Presentation at the USP Workshop of Economically

Motivated Adulteration of Food Ingredients and Dietary Supplements, September 26–27, 2013.

6

For other background information, CRS Report RL34124, Seafood Marketing: Combating Fraud and Deception.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Some cases might not initially appear to involve intentional adulteration, except on closer

examination. Charges of fraud were part of the federal criminal indictment charging former

officials of the Peanut Corporation of America with numerous offenses in connection with the

Salmonella outbreak in 2009—which killed 9 people and sickened 700—since company officials

were found to have sold and distributed product known to be contaminated.7 That case resulted in

one of the largest product recalls in U.S. history, including 3,912 products that contain peanut

butter and peanut paste ingredients, such as cookies, crackers, cereal, candy, ice cream, pet treats,

and other foods, which were manufactured by more than 200 companies.8

Risks from other types of fraudulent foods are not as well-documented and may be less

immediate or may never be known. Generally, only those who have knowledge of the fraud are

those who commit the fraud. In some cases, independent tests might uncover fraud. For example,

FDA testing upon import has documented the presence of unapproved chemicals in honey, which

have triggered import alerts.9 Reports indicate that honey from China may contain certain

unapproved antibiotics or other agricultural chemicals.10 Reports also indicate that some fruit

juices may be made from or diluted with juice from rotten fruit and may contain toxic mold.11 In

recent years, fraud involving the addition of certain food processing aids (known as “clouding

agents”) has raised concern given the potential public health risks and reportedly increased use in

certain highly processed foods.12 Some fraud cases might only be uncovered following an

investigation in the wake of a public health event, such as when pet food adulterated with

melamine caused the deaths of dogs and cats in the United States. Some fraud cases, however,

might never be discovered even though they could contribute to chronic long-term health

consequences.

Other food fraud concerns might not result in a public health or food safety crisis, but instead

deprive the food buyer of the product they think they are getting. Most food fraud cases involve

the substitution of a high-value product with a less expensive or lower quality alternative. Such

cases include cheaper products mislabeled as extra virgin olive oil from Italy, wild Alaskan

salmon, caviar, and pomegranate juice or juices from other “super” fruit. In another example, in

Europe in early 2013, it was reported that products labeled as containing beef were found to

actually contain 80%-100% horsemeat, which the meat supplier had knowingly failed to report to

local authorities.13 Although the horsemeat incident ultimately did not result in public health

consequences, initial concerns about potential health risks due to, for example, phenylbutazone14

resulted in a substantial expenditure of public resources over the course of the investigation. Such

7

Department of Justice press release, “Former Officials and Broker of Peanut Corporation of America Indicted Related

to Salmonella-Tainted Peanut Products,” February 21, 2013.

8

For other background information, see CRS Report R40450, Penalties Under the Federal Food, Drug, and Cosmetic

Act (FFDCA) That May Pertain to Adulterated Peanut Products.

9

See, for example, Import Alert # 36-03 (Detention Without Physical Examination of Honey Due to Chloramphenicol),

June 20, 2013, http://www.accessdata.fda.gov/cms_ia/importalert_110.html.

10

A. Schneider, “Tests Show most Store Honey Isn’t Honey,” Food Safety News, November 7, 2011.

11

See, for example, FDA, “Patulin in Apple Juice, Apple Juice Concentrates and Apple Juice Products,” September

2001; and “China to investigate rotten fruit juice,” China.org,cn, September 24, 2013.

12

USP press release, “Food Fraud Reports Up 60% Since 2010,” January 23, 2013.

13

European Commission, “Q&A on Horsemeat,” http://ec.europa.eu/food/food/horsemeat/; and Ireland’s Department

of Agriculture, Food and the Marine, “Equine DNA and Mislabeling of Processed Beef Investigation,” March 2013.

14

Phenylbutazone is a non‐steroidal anti‐inflammatory medicine to treat musculoskeletal disorders, such as rheumatoid

and arthritis, and is authorized for medicinal use in horses that are not intended for human consumption.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

cases also erode consumer confidence and may cause other concerns for a variety of societal or

cultural reasons.

The Grocery Manufacturers Association (GMA) estimates that fraud may cost the global food

industry between $10 billion and $15 billion per year,15 affecting approximately 10% of all

commercially sold food products.16 However, most researchers acknowledge that the full scale of

food fraud “may be unknown or even possibly unknowable”17 even though the number of

documented incidents is “most likely a fraction of the true number of incidents, since the goal of

adulteration for economic gain is not to be detected.”18 Compared to the trillions of dollars spent

on food and food ingredients globally each year, however, “the prevalence of food fraud is

ultimately very low.”19 Fraud resulting in a food safety or public health risk event, however, could

have significant financial or public relations consequences for a food industry or company. GMA

estimates that fraud costs food businesses in terms of lost sales, estimated between 2% and 15%

of annual revenues, as well as possible bankruptcies if adverse public health consequences occur.

The text box on the next page describes some of the types of foods and food ingredients

associated with fraud based on available research and information.

Addressing food fraud concerns has become exceedingly complicated by rising U.S. imports and

increased globalization of the world’s food and agricultural supplies. Increasingly, multiple

product ingredients and inputs are sourced from a range of countries, both in terms of individually

sourced products and ingredients between individual food companies/importers as well as in

terms of internally sourced products from foreign-owned entities within a larger multinational

company (such as global sourcing between parent and subsidiary). It is difficult to detect and

trace not only the source of unintentional contamination and related food safety concerns, but it is

often more difficult to detect and trace-back instances of intentional product fraud, especially in

highly processed foods with multiple ingredients and inputs from multiple suppliers.

This report provides an overview of issues pertaining to food fraud and “economically motivated

adulteration” or EMA, a category within food fraud. First, the report provides general background

information on food fraud and EMA, including how it is defined and the types of fraud, as well as

how food fraud fits into the broader policy realm of food safety, food defense, and food quality.

Second, the report provides available information about foods and ingredients with reported cases

of fraud from two databases: (1) the United States Pharmacopeial Convention (USP) Food Fraud

Database and (2) the National Center for Food Protection and Defense (NCFPD) EMA Incident

Database. Finally, the report describes previous and ongoing federal and congressional actions to

address food fraud.

15

GMA, Consumer Product Fraud, Deterrence and Detection, 2010, http://www.gmaonline.org/downloads/wygwam/

consumerproductfraud.pdf; and A. Kircher, NCFPD, “Tools for Protecting the Nation’s Food Supply,” June 5, 2012.

16

Estimated by the Food Standards Agency of the U.K., as reported by K. Everstine and A. Kircher, “The Implications

of Food Fraud,” Food Quality & Safety magazine, June/July 2013.

17

J. Spink and Z.L. Fejes, “A review of the economic impact of counterfeiting and piracy methodologies and

assessment of currently utilized estimates,” International Journal of Comparative and Applied Criminal Justice,

September 2012.

18

NCFPD, “EMA Frequently Asked Questions,” http://www.ncfpd.umn.edu/.

19

Comments attributed to John Spink, Michigan State University’s Food Fraud Initiative, as reported by M. Oaklander,

“11 Most Fraudulent Foods,” Prevention.com.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Leading Food Categories with Reported Cases of Food Fraud

Olive Oil. Olive oil is often substituted with a lower cost alternative, whether it is regular olive oil instead of higherpriced extra virgin olive oil or a less expensive variety from Greece or Turkey, instead of from Italy as the label

claims. In such cases the fraud was associated with efforts to defraud the European Union’s farm support program,

which subsidizes olive oil, as part of the Common Agricultural Policy (CAP). In some cases an alternate seed or nut oil

may be sold as or thinned out with hazelnut, soybean, corn, peanut, sunflower, safflower, walnut, vegetable, canola, or

palm oil, and in one case, lard. Some combinations contained no olive oil. The use of nut or legume oils could pose a

problem for those with certain food allergies. In rare cases, non-food-grade oil may be added, such as rapeseed.

Fish and Seafood. Some higher-value fish and seafood are replaced with cheaper, more abundant fish. A report by

Oceana found that fish samples purchased at grocery stores, restaurants, and sushi bars in major cities were often

mislabeled, including red snapper (actually tilefish); white tuna and butterfish (actually escolar); wild Alaskan salmon

(actually farmed Atlantic salmon); caviar (actually catfish roe); and monkfish (puffer fish). Other types of substitutions

have involved halibut, sole, grouper, and striped bass. Some substitutions have involved fish or seafood associated with

certain types of fish poisoning or allergens. Other substitutions are intended to evade import and other restrictions.

Milk and Milk-based Products. Milk from bovine cows has had milk from other types of animals, such as sheep,

buffalo, and goats-antelopes, added to it, but also adulterated with reconstituted milk powder, urea, and rennet,

among other products (oil, detergent, caustic soda, sugar, salt, and skim milk powder). Adulterated milk may also be

watered down and then supplemented with melamine to artificially raise the apparent protein content and hide

dilution. Melamine, an organic base chemical, is widely used in plastics, adhesives, and other consumer products, and is

known to pose a public health threat. Adulterated milk might also be added into infant formula and other milk-based

products. Baby formula is a common target for retail theft, often by tampering with the sell-by codes to move expired

product.

Honey, Maple Syrup, and Other Natural Sweeteners. Honey might have added sugar syrup, corn syrup,

fructose, glucose, high-fructose corn syrup, and beet sugar, without being disclosed on the label. Honey from a “nonauthentic geographic origin” is also common, such as cases where honey from China is transshipped through another

Asian country and falsely sold as honey from the second country—usually to avoid higher customs duties and tariffs

that would be imposed on honey from China. Some of this honey might also contain unapproved antibiotics or other

additives and heavy metals. Maple syrup is sometimes thinned out with sugar or corn syrup.

Fruit Juice. Juices might be watered down, or a more expensive juice (such as from pomegranates or other “super”

fruit) might be cut with a cheaper juice (such as apple or grape juice). Some juice may be only water, dye, and sugary

flavorings, although fruit is the listed ingredient on the label. Orange juice has been shown to sometimes contain

added unlisted lemon juice, mandarin juice, grapefruit juice, high fructose corn syrup, paprika extract, and beet sugar.

Apple juice has been shown to have added unlisted grape juice, high fructose corn syrup, pear juice, pineapple juice,

raisin sweetener, fig juice, fructose, and malic acid.

Coffee and Tea. Ground coffee might be cut with leaves and twigs, as well as roasted corn, ground roasted barley,

and roasted ground parchment. Instant coffee may include chicory, cereals, caramel, more parchment, starch, malt,

and figs. Tea may contain leaves from other plants, color additives, and colored saw dust.

Spices. Saffron is the world’s most expensive spice, and has been found to have added glycerin, sandalwood dust,

tartrazine (a yellow dye), barium sulfate, and borax. Ground black pepper has been shown to have added starch,

papaya seeds, buckwheat, flour, twigs, and millet. Vanilla extract, turmeric, star anise, paprika, and chili powder are

other spices prone to fraud. Sudan red dyes have been used to color paprika, chili powders, and curries, but are also

known carcinogens and are banned for use in foods.

Organic Foods and Products. Using fraudulent certification to market, label, or sell non-organic (conventionally

produced) agricultural products as USDA-certified “organic” is a violation of U.S. law and federal National Organic

Program (NOP) regulations. Products fraudulently labeled as “organic” have been detected by USDA for a range of

foods and food ingredients from both domestic and international suppliers.

Clouding agents. “Clouding agents” or food processing aids “to enhance the appeal or utility of a food or food

component,” such as palm oil and other allowed food ingredients, are often used in fruit juices, jams, and other foods.

Of particular concern is the fraudulent replacement or addition of the plasticizer Di(2-ethylhexyl) phthalate (DEHP)

and other related phthalates, as a substitute for other ingredients. DEHP may also be used in food contact materials,

such as seals and packaging. DEHP is associated with public health risks, including cancer and reproductive concerns.

Source: CRS compilation from information reported by USP, Michigan State University, NCFPD and researchers at

the University of Minnesota, Oceana, Consumers Union, Food Chemical News, and the Rodale Institute. Unless

otherwise indicated, “adulteration” and “misbranding” of foods is prohibited under various FDA and USDA laws.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Existing Definitions

There is no statutory definition of food fraud or “economically motivated adulteration” or EMA

of foods or food ingredients, which is generally considered a subset of food fraud. However, the

U.S. Food and Drug Administration (FDA) adopted a “working definition” for an April 2009

public meeting to raise awareness and solicit public input regarding economically motivated

adulteration of FDA-regulated products. For the purposes of the workshop, FDA defined

“economically motivated adulteration” as the:20

fraudulent, intentional substitution or addition of a substance in a product for the purpose of

increasing the apparent value of the product or reducing the cost of its production, i.e., for

economic gain. EMA includes dilution of products with increased quantities of an already-present

substance (e.g., increasing inactive ingredients of a drug with a resulting reduction in strength of

the finished product, or watering down of juice) to the extent that such dilution poses a known or

possible health risk to consumers, as well as the addition or substitution of substances in order to

mask dilution.

Other countries generally also do not have established legal definitions of food fraud. A recent

European Union (EU) report on food fraud states the EU laws do not provide for a “generally

acknowledged definition of food fraud” despite an extensive legislative framework focused on

food safety.21 The only general guideline is found in EU regulations requiring that food labeling,

advertising, presentation, and packaging “shall not mislead consumers.”22 However, these

requirements reportedly vary among EU member states and food fraud in Europe remains largely

undetected, similar to that in the United States. The United Kingdom’s Food Standards Agency

(FSA) describes “food fraud” as the deliberate placement on the market, for financial gain, with

the intention of deceiving the consumer, covering two main types of fraud.23 These include the

sale of food which is unfit and potentially harmful24 as well as the deliberate misdescription of

food, such as products substituted with a cheaper alternative.25

Researchers and industry groups actively working in this area have myriad definitions of food

fraud and EMA.

Broadly speaking, food fraud is a type of product fraud. According to food safety researchers at

Michigan State University’s (MSU’s) Food Fraud Initiative:26

20

74 Federal Register 64: 15497-15499, April 6, 2009.

European Parliament, Committee on the Environment, Public Health and Food Safety draft report “on the food crisis,

fraud in the food chain and the control thereof,” (2013/2091(INI)).

22

Regulation 178/2002 on general principles and requirements regarding food labeling, advertising, presentation, and

packaging.

23

FSA, “Food Fraud”, http://www.food.gov.uk/enforcement/enforcework/foodfraud/#.Un46Kz_qSSo.

24

Cited examples include the recycling of animal by-products back into the food chain packing and selling of beef and

poultry with an unknown origin knowingly selling goods which are past their “use by” date.

25

Cited examples include farmed salmon sold as wild, and Basmati rice adulterated with cheaper varieties making false

statements about the source of ingredients.

26

J. Spink and in D.C. Moyer, Backgrounder: Defining the Public Health Threat of Food Fraud, National Center for

Food Protection and Defense, April 2011.

21

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Food fraud is a collective term used to encompass the deliberate and intentional substitution,

addition, tampering, or misrepresentation of food, food ingredients, or food packaging; or false or

misleading statements made about a product for economic gain.

The United States Pharmacopeial Convention (USP) states:27

Food fraud in the context of food ingredients refers to the fraudulent addition of non-authentic

substances or removal or replacement of authentic substances without the purchaser’s knowledge

for economic gain of the seller. It is also referred to as economic adulteration, economically

motivated adulteration, intentional adulteration, or food counterfeiting.

In this context, “adulterant” is defined as “the undesirable substance” or “fraudulently added

material” in a fraudulent food or food ingredient. In the case of food fraud, the adulterants used

often are unconventional and designed to avoid detection through routine inspection.28

According to researchers at the National Center for Food Protection and Defense (NCFPD) at the

University of Minnesota:29

Economically motivated adulteration (EMA) is the intentional sale of substandard food or food

products for the purpose of economic gain. Common types of EMA include intentional

substitution of an authentic ingredient with a cheaper product, dilution with water or other

substances, flavor or color enhancement using illicit or unapproved substances, and substitution

of one species with another.

The Grocery Manufacturers Association (GMA) provides the following definitions of “economic

adulteration” as part of its report on consumer product fraud in the food, beverage, and consumer

product industry:30

Economic adulteration is defined as the intentional fraudulent modification of a finished product

or ingredient for economic gain through the following methods: unapproved enhancements,

dilution with a lesser-value ingredient, concealment of damage or contamination, mislabeling of a

product or ingredient, substitution of a lesser-value ingredient or failing to disclose required

product information.

These definitions broadly reference three types of fraud, as defined by USP and other university

researchers, namely:31

•

complete or partial replacement of a food ingredient or valuable authentic

constituent with a less expensive substitute (or alternative animal species in the

case of some meat and fish);

•

addition of small amounts of a non-authentic substance to mask inferior quality

ingredient (or excess packing ingredients, including water and ice); and

27

USP, Food Fraud Database, Glossary of Terms, http://www.foodfraud.org/glossary-terms.

“Food Ingredients Most Prone to Fraudulent Economically Motivated Adulteration,” Science Daily, April 5, 2012.

Unconventional adulterants may trigger food safety concerns, as they might not be approved for use in food.

29

NCFPD, “EMA Frequently Asked Questions,” http://www.ncfpd.umn.edu.

30

GMA, Consumer Product Fraud, Deterrence and Detection, 2010.

31

J.C. Moore, J. Spink, and M. Lipp, “Development and Application of a Database of Food Ingredient Fraud and

Economically Motivated Adulteration from 1980 to 2010,” Journal of Food Science, Vol. 77, Nr. 4, 2012; and USP,

Food Fraud Database, Glossary of Terms, http://www.foodfraud.org/glossary-terms.

28

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

•

removal or intentional omission of an authentic and valuable constituent in a

food product or food ingredient.

Also included are false claims and non-declarations based either on geographic, species,

botanical, varietal origin, and production processes in order to provide economic benefit through

the substitution of a particular food or food ingredient with a lower priced or a lower quality

ingredient. Fraud may also be motivated in cases where a particular food or food ingredient is in

short supply, triggering the motivation to substitute one input for another. In other cases false

declarations of origin are intended to evade taxes and tariffs in importing countries. Food fraud

also includes smuggling, tampering, and stolen goods. The text box on the next page provides

more detailed information.

Risks to Food Protection

Figure 1 provides a matrix of food protection risk and illustrates how food fraud fits into the

broader policy realm of food safety, food defense, and food quality.32 Although these concepts

may not always fit neatly into these categories and there may be overlap across these categories,

this matrix provides a useful, and widely cited, framework for differentiating among these food

protection areas.

In general, food fraud and food defense (agro-terrorism) are both intentional. Food fraud is

always economically motivated. Motivation in the case of food defense includes the intention to

inflict public harm or threaten consumers, and is considered to be food fraud.33 Food fraud

usually is perpetrated by actors normally involved in the food chain that have regular access to

the food product (e.g., manufacturers or distributors). Problems with food defense usually are

perpetrated by outsiders, including terrorists, who do not normally have access to the food

product. NCFPD reports that most incidents of food fraud generally do not result in public health

harm; however, sometimes perpetrators of food fraud “make mistakes and unintended health

consequences result.”34 Table 1 contrasts the different types of food-related risks, and provides

examples, causes and motivations, primary and secondary effects, and also types of public health

risks.

32

Based on work published in J. Spink and D.C. Moyer, “Defining the Public Health Threat of Food Fraud,” Journal of

Food Science, 2011, and other resources from MSU’s Food Fraud Initiative (http://foodfraud.msu.edu/).

33

CRS communication with Karen Everstine, NCFPD, December 27, 2013. For additional information on food

defense, see section titled “Food Defense” in CRS Report R42985, Issues in Homeland Security Policy for the 113th

Congress; and CRS Report RL34160, The National Bio- and Agro-Defense Facility: Issues for Congress. For more

direct assistance, contact (name redacted), Specialist in Public Health and Epidemiology ([redacted]@crs.loc.gov, 7-....)

or (name redacted), Specialist in Agricultural Policy ([redacted]@crs.loc.gov, 7-....).

34

NCFPD, “EMA Frequently Asked Questions,” http://www.ncfpd.umn.edu.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Types of Food Fraud

(1) Replacement: Complete or partial replacement of a food ingredient or valuable authentic constituent with a less

expensive substitute, usually achieved through the addition, dilution, or extension of an authentic ingredient with an

adulterant or mixture of adulterants. Examples include addition of melamine to milk to artificially increase apparent

protein contents; addition of water and citric acid to lemon juice to fraudulently increase the titratable acidity of the

final juice product; and overtreating frozen fish with ice (adds extra water, potentially unsanitary). Included are false

claims and non-declarations:

•

False declaration of geographic, species, botanical, or varietal origin (e.g., substitution of less expensive

cow’s milk for sheep's or goat's milk; substitution of common wheat for durum wheat; substitution of Greek or

Turkish olive oil labeled as Italian olive oil; substitution of synthetically produced vanillin for botanically derived

natural vanillin); farmed salmon sold as wild; and the sale of meat from animals that have been stolen and/or

illegally slaughtered, such as wild game animals that may have been poached.

•

False declaration of origin to evade taxes/tariffs (e.g., U.S. imports of catfish from Vietnam labeled as

grouper to avoid anti-dumping duties; transshipment of Chinese products, such as shrimp and honey, through

other Asian nations to avoid anti-dumping duties or to mask the true origin of potentially unsafe product).

•

False declaration of production process (e.g., fraudulent labeling of a synthetically derived flavor chemical as

being “naturally” derived; food falsely labeled or certified as organically produced); or poor quality filtered honey

or a honey substitute product labeled as raw honey, which reportedly has medicinal properties.

Such fraudulent practices are generally intended to provide economic benefit through the substitution of a particular

food or food ingredient with a lower priced or a lower quality ingredient. In some cases, short supply of a particular

food or food ingredient might trigger the motivation to substitute one input for another, for example, when horse

meat was found in prepared meals as a result of a reduced European supply of beef and other meat products.

(2) Addition: Addition of small amounts of a non-authentic substance to mask inferior quality ingredient. An

example is the addition of a color additive (such as Sudan Red dyes) to enhance the color of poor quality paprika.

(3) Removal: Removal or intentional omission of an authentic and valuable constituent without the purchasers’

knowledge. One example is the removal of non-polar constituents from paprika (e.g., lipids and flavor compounds) to

produce paprika-derived flavoring extracts, or “defatted” paprika, which lacks valuable flavoring compounds, as normal

paprika. Another example is poor quality honey that has been filtered to remove pollen or other residue from the

beehive, in order to make it difficult to determine the honey’s botanical and geographic origin or to circumvent the

ability to trace and identify the actual source of the honey.

Source: J.C. Moore, J. Spink, and M. Lipp, “Development and Application of a Database of Food Ingredient Fraud and

Economically Motivated Adulteration from 1980 to 2010,” Journal of Food Science, Vol. 77, Nr. 4, 2012; and USP, Food

Fraud Database, Glossary of Terms, http://www.foodfraud.org/glossary-terms.

Note: “Transshipment” refers to the transfer of a shipment from one carrier or vessel to another during transit,

usually to hide the identity of the port or country of origin.

In contrast, problems with food safety and food quality are unintentional. Both food quality and

food safety incidents may result in an economic impact to a particular food or food ingredient

industry, for example, due to reduced purchases or brand equity, but also from product recalls,

process controls, and liability in the case of food safety. Food safety concerns can also cause a

threat to public health and create public fear. Adulteration will cause a loss of the consumer’s

trust in the food supply chain, and a loss in trust among regulators, industry, and U.S. trading

partners, and may result in market and trade disruptions. Unintentional adulteration involving

food quality concerns might also occur due to environmental factors, and packaging, storage, and

distribution issues, among other factors.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Figure 1. Food Protection Risk Matrix

Source: J. Spink and D.C. Moyer, “Defining the Public Health Threat of Food Fraud,” Journal of Food Science,

2011.

Table 1. Food Protection Risk: Examples, Cause and Effects

Cause and

Motivation

Effect

Public Health

Risk Type

Secondary

Effect

Risk Type

Example

Food Quality

Accidental

bruising of fruit

Mishandling

Unsalable

product or

possible

additional

contamination

None, or

possible food

safety

Reduced

product/brand

equity or food

safety incident

Food Fraud

Intentional

adulteration of

milk with

melamine

Increased profit

margins

Toxic poisonings

Food safety

Public fear and

possible lower

prices industrywide

Food Safety

Unintentional

contamination of

raw vegetables

with E. coli

Limited field

protection and

control during

harvesting and

processing

Illness and/or

death

Food safety

Damaged industry,

recall expense,

and public fear

Food Defense

Intentional

contamination of

ground beef with

nicotine

Revenge against

the store/manager

through injury to

consumers

Nonlethal

poisonings

Food defense

Adulterated

product, damaged

industry, recall

expense, public

fear

Source: J. Spink and D.C. Moyer, “Defining the Public Health Threat of Food Fraud,” Journal of Food Science,

2011.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Available Data and Information Repositories

Review of Available Database Information

Efforts are ongoing to compile and capture current and historical data on food fraud and EMA

incidents through the creation of databases and repositories. Although the information in these

databases is not comprehensive and may contain certain limitations, it does represent the best

information available and provides a first step to understand the scope and scale of food fraud as

a way to further detect, combat, and prevent future fraud. The information contained in these

databases is from the University of Minnesota as well as the United States Pharmacopeial

Convention (USP), a long-standing scientific nonprofit organization. In addition, researchers

from Michigan State University conducted further analysis of the USP databases, along with USP

researchers. These databases provide a relatively new resource to examine food fraud incidents,

and were first published starting in 2012 and 2013. Since then, information from these databases

has been published in peer reviewed journal articles and presented at professional conferences by

both academic researchers and industry leaders.35 Nevertheless, because there is no single

comprehensive surveillance system to detect food fraud in the United States or worldwide, it is

not possible to know what portion of food fraud incidents may be captured by these databases,

and whether or not the information in these databases represents the universe of potential food

fraud incidents.

Information in these databases also has been widely cited by academic researchers, government

officials, and the media to rank the leading foods and food ingredients that are most often

associated with fraud. For example, information in the USP Food Fraud Database was used by the

European Parliament to help identify the leading fraudulent foods, as part of its recent draft report

calling for increased oversight of food fraud.36 NDFPD’s database, and preliminary analysis of

information obtained from USP’s database, was originally funded by the U.S. Government

through funding from the Department of Homeland Security (DHS), FDA, and the U.S.

Department of Agriculture (USDA), as well as funding from the private sector. USP’s database

and related activities are self-funded and provided in accordance with USP’s mission to support

public health, and are not supported by funding from any outside agency.

The two available databases are:

1. United States Pharmacopeial Convention (USP) Food Fraud Database, and

2. National Center for Food Protection and Defense (NCFPD) EMA Incident Database.

USP’s database is open and publicly accessible; NCFPD’s databases are accessible upon request.

Information in these databases is from available scholarly journal articles and industry analyses

and lab tests (where available), as well as media reports, about foods and food ingredients that are

vulnerable to fraudulent manipulation. These records are based on English-language scholarly

35

For example, presentations and comments at the USP Workshop of Economically Motivated Adulteration of Food

Ingredients and Dietary Supplements, Rockville, MD, September 26–27, 2013.

36

European Parliament, Committee on the Environment, Public Health and Food Safety draft report “on the food crisis,

fraud in the food chain and the control thereof” (2013/2091[INI]).

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

and/or media sources. Both databases are largely global in scope and broadly represent fraud in

foods and food ingredients sold commercially worldwide. Undoubtedly the information in these

databases does not capture all cases of food fraud and EMA, or incidents that may occur in smallscale markets or on a non-commercial scale or incidents that may or may not be reported in

various non-English speaking information outlets.

Since those who commit fraud actively seek to avoid detection, some food fraud and EMA cases

might not be captured in either database. In fact, in some cases, records in the database may be

more reflective of where research is being conducted or where resources have been dedicated in a

concerted effort to root out fraud, rather than provide an exhaustive accounting of all fraud cases.

Differences between these two databases, including how they were compiled and the type of

records they reference, among other things, may result in differences in how different foods and

food ingredients may be ranked in terms of their susceptibility to food fraud and EMA.

These databases do not address fraud involving “dietary supplements.”37 Dietary supplements are

a special category of food that includes finished products (e.g., a vitamin D tablet) that contain

one or more “dietary ingredients” or are components of those finished products (e.g., vitamin D

added to a food product such as breakfast cereal).38 Like food fraud, fraud involving dietary

supplements is a type of product fraud with documented concerns involving public health risks.39

Additional research in this area is currently being considered, including development of a

database of reported cases of dietary supplement fraud.40

USP Food Fraud Database

The United States Pharmacopeial Convention (USP) Food Fraud Database is a public database

that catalogues available analytical methods to detect and identify problematic food ingredients,

which in turn provides a repository for ingredient fraud reports.41 The database is comprised of

both “scholarly” and “media” reports from available food science scholarly sources (and

undocumented industry analyses, where available) and mainstream English-language media. The

database is not an “incidents” database where individual records have been further grouped by

source and time period, but instead it catalogues reports involving detection methods and analyses

of food fraud incidents.42 As a result, information in the database may be more representative of

37

For general information on dietary supplements, see CRS Report R43062, Regulation of Dietary Supplements, or

contact (name redacted), Anal

yst in Public Health and Epidemiology ([redacted]@crs.loc.gov, 7-....).

38

V.M. Wheatley and J. Spink, “Defining the Public Health Threat of Dietary Supplement Fraud,” Comprehensive

Reviews in Food Science and Food Safety, Vol.12, 2013.

39

D.S. Fabricant, “Dietary Supplement Adulteration”. Presentation and comments at the USP Workshop of

Economically Motivated Adulteration of Food Ingredients and Dietary Supplements, September 26–27, 2013.

40

Comments by J. Spink, MSU, November 12, 2013, as part of the massive open online course (MOOC) on food fraud.

41

USP Food Fraud Database, http://www.foodfraud.org/, and the USP, Food Chemicals Codex, 8th Edition. For

information: http://www.foodfraud.org/frequently-asked-questions. USP is a “scientific nonprofit organization that sets

standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements

manufactured, distributed and consumed worldwide” (http://www.usp.org/about-usp). Other information is at J. Moore,

“The USP Food Fraud Database.” Presentation at the USP Workshop of Economically Motivated Adulteration of Food

Ingredients and Dietary Supplements, September 26–27, 2013.

42

Detection technologies recorded in the database include high-performance liquid chromatography; standards for

infrared spectroscopy; gas chromatography; isotope ratio mass spectrometry; hyphenated mass spectrometry methods;

near infrared spectroscopy; polymerase chain reaction; capillary electrophoresis; enzyme linked immunosorbent assay;

(continued...)

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

foods that are the most researched, and not necessarily foods that are the most adulterated. The

USP database is organized by food ingredient categories and identifies the type of adulterant

reported for each documented record and broadly classifies each record by the type of fraud (e.g.,

addition, replacement, removal), but does not provide other information such as where the

product was originally produced.

The initial version of the database was published in 2012 in the USP’s 8th Edition of the Food

Chemicals Codex43 and was accompanied by initial analyses of the database records published in

the April 2012 issue of the Journal of Food Science,44 with the support of researchers at the

MSU’s Food Fraud Initiative. Initial funding for MSU’s contribution to the manuscript was

provided by the National Center for Food Protection and Defense (NCFPD) through DHS, with

other funding from FDA and USDA.45 The USP database was updated in 2013 and now covers

the period from 1980 through 2012, and contains nearly 2,100 records.

NCFPD EMA Incident Database

The National Center for Food Protection and Defense (NCFPD) EMA Incident Database is

another database, which differs in that it catalogs isolated EMA incidents and is available to

authorized users upon request.46 (NCFPD is a University of Minnesota-led consortium and has

been a Homeland Security Center of Excellence since July 2004.)47 As part of the database, an

“incident” is defined as:48

a documented, isolated occurrence of EMA in a single food product or group of associated food

products occurring within a defined time frame and with a distinct group of perpetrators.

Incidents that are difficult to isolate to a specific time frame and/or group of perpetrators, or with

characteristics common to multiple perpetrators, are entered as a single incident.

For example, the melamine adulteration of infant formula in China in 2007-2008 is recorded as

one incident. Individual records therefore have been further grouped by adulterant (e.g.,

melamine) and time period when the incident is estimated to have occurred. The database records

also do not include information on issues that might be of concern but that remain undocumented

(...continued)

thin-layer chromatography; site-specific natural isotope fractionation; mid-infrared spectroscopy; Raman spectroscopy;

nuclear magnetic resonance spectroscopy; high-performance anion exchange chromatography; resonance spectroscopy;

high-performance anion exchange chromatography; and differential scanning calorimetry.

43

Freely available online at http://www.foodfraud.org/.

44

J.C. Moore, J. Spink, and M. Lipp, “Development and Application of a Database of Food Ingredient Fraud and

Economically Motivated Adulteration from 1980 to 2010,” Journal of Food Science, Vol. 77, Nr. 4, 2012.

45

Comments by J. Spink, MSU, November 12, 2013, as part of the massive open online course (MOOC) on food fraud.

See also NCFPD, Final Report: 2007-2011, DHS Award #2007-ST-061-000003, p. 132.

46

Information in the NCFPD EMA Incident Database is accessible via FoodSHIELD by request. For more information,

see https://www.foodshield.org/index.cfm/join-registration/membership/.

47

As a Homeland Security Center of Excellence, NCFPD is a multidisciplinary and action-oriented research

consortium. For more information, see DHS, “Science & Technology Directorate Centers of Excellence,”

https://www.dhs.gov/st-centers-excellence; and NCFPD, “NCFPD’s Mission: Defending the Safety of the Food System

Through Research and Education,” http://www.ncfpd.umn.edu/default/assets/File/2011-03-7_NCFPD_Flyer.pdf

48

NCFPD, “NCFPD EMA Incidents Database,” http://ema.foodshield.org/ (may require request for access). Also see

NCFPD news release, “Preventing Economically Motivated Adulteration,” February 4, 2013. Cited sources include

LexisNexis, PubMed, Google, FDA consumer and recall records, state reports, and the E.U. Rapid Alert System for

Food and Feed (RASFF) portal.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

in the public domain. The database tracks EMA incidents in food products since 1980. There were

1,054 records in the database in mid-2012, covering 302 incidents.49 The EMA Incident Database

identifies the type of adulterant reported for each documented incident and classifies each by the

type of adulteration (including substitution/dilution, unapproved additives, mislabeling,

transshipment/origin masking, and port shopping),50 and also provides information on where the

product was originally produced based on an examination of the available information.

Initial analyses of the EMA Incidents Database records were published in the April 2013 issue of

the Journal of Food Protection.51 The database and related work to develop predictive models and

case studies are intended to help characterize discrete EMA incidents to better understand the

incentive behind the adulteration, including the adulterant used, how the adulteration was

discovered, and how to detect and deter future incidents and protect the U.S. food supply from

deliberate or intentional acts of contamination or tampering.52 In addition to the EMA Incidents

Database, NCFPD is also developing an EMA Susceptibility Database that includes evaluations

of the monographs in the USP Food Chemicals Codex for susceptibility to EMA.53 NCFPD is

also working with DHS on other projects, including development of an assessment tool to

determine and document the most critical food and agriculture infrastructure at the state level.54

Leading Reported Types of Fraud

These available databases provide information on the types of foods and food ingredients

associated with food fraud. How these products and ingredients are ranked, however, may differ

considerably among various reports. Specifically, overall product rankings of the leading reported

fraudulent foods and food ingredients may differ depending on:

•

database referenced (i.e., whether USP or NCFPD database);

•

source or type of records referenced (i.e., in the USP database, ranking differs

based on whether compiled from the “scholarly” or “media” or total records; in

the NCFPD database, ranking is based on number of “incidents”);

•

time period (1980 through 2010 or 1980 through 2012); and

•

organization compiling the data (i.e., whether conducted by USP or NCFPD, or

whether conducted by an outside organization using data from one of the

databases).

49

A. Kircher, NCFPD, “Tools for Protecting the Nation’s Food Supply,” June 5, 2012; and information compiled by

CRS from records in the NCFPD EMA Incident Database (database accessed November 14, 2013).

50

“Port shopping” refers to when exporters and importers choose a particular port on the basis of their assessment of

Customs’ treatment, rather than on the quality of physical facilities and efficiency.

51

K. Everstine, J. Spink, and S. Kennedy, “Economically Motivated Adulteration (EMA) of Food: Common

Characteristics of EMA Incidents,” Journal of Food Protection, Vol. 76, Nr. 4, April 2013. The analyses in this article

covered 137 EMA incidents.

52

Comments by Amy Kircher, NCFPD, USP Workshop of Economically Motivated Adulteration of Food Ingredients

and Dietary Supplements, September 26, 2013; and NCFPD, “EMA Frequently Asked Questions.”

53

Additional information and the database is available at http://www.foodshield.org.

54

DHS, “National Infrastructure Protection Plan: Food and Agriculture Sector,” and DHS, Food and Agriculture

Sector-Specific Plan: An Annex to the National Infrastructure Protection Plan, 2010.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

USP Food Fraud Database

The initial version of the United States Pharmacopeial Convention (USP) Food Fraud database

published in 2012 covered both “scholarly” and “media” records from 1980 through 2010, and

was accompanied with analysis conducted by researchers at MSU and USP. This first version of

the database consisted of a total of 1,305 records covering 361 discrete food ingredients that were

based on 660 references (Table 2).

Records in the USP database indicate that the leading reported types of fraud by specific

ingredient among the database’s scholarly records (1980-2010) were olive oil (16%), milk (14%),

honey (7%), saffron (5%), orange juice (4%), coffee (3%), and apple juice (2%).55 Figure 2

provides a consolidated breakdown by major food ingredient category. By major food ingredient,

oils (24%), milk (14%), and spices (11%) account for nearly 50% of all reported cases.

Records in the USP database indicate that the leading reported types of fraud by specific

ingredient among the database’s media records (1980-2010) were fish (9%), honey (6%), olive oil

(4%), chili powder (4%), milk (3%), black pepper (3%), and caviar (2%). Figure 3 provides a

consolidated breakdown by major food ingredient category whereby natural flavoring

complexes56 (30%) and spices (19%) account for nearly 50% of all reported cases.

The 2013 updates to the USP Food Fraud Database added another 792 records from 264

additional references to the database, consisting mostly of new information published in 2011 and

2012. This raised the total number to 2,097 records, based on 924 references (Table 2).

Table 2. Scope of USP Food Fraud Database

2012 Publication and 2013 Update

Database Version

Scholarly Records

Media Records

Total

Number of Records

1,054

251

1,305

Number of Ingredients

250

147

397

Number of References

575

85

660

Total Number of Records (since 1980)

1,648

449

2,097

Total Number of References (since 1980)

742

182

924

2012 Publication (1980-2010 data)

2013 Update (mostly additional 2011-2012 data)

Source: As reported in J.C. Moore, J. Spink, and M. Lipp, “Development and Application of a Database of Food

Ingredient Fraud and Economically Motivated Adulteration from 1980 to 2010,” Journal of Food Science, Vol. 77,

Nr. 4, 2012; and A.G. Ebert, “The Food Chemicals Codex EMA Activities: The Food Fraud Database – What’s

Next?” Presentation at the USP Workshop of Economically Motivated Adulteration of Food Ingredients and

Dietary Supplements, September 26–27, 2013.

55

J.C. Moore, J. Spink, and M. Lipp, “Development and Application of a Database of Food Ingredient Fraud and

Economically Motivated Adulteration from 1980 to 2010,” Journal of Food Science, Vol. 77, Nr. 4, 2012.

56

Natural flavoring complexes refer to essential oils, oleoresin, essence or extractive, which contains the flavoring

constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root,

leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products used as a food

ingredient for flavoring.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Figure 2. Leading Reported Types of Fraud, USP Scholarly Records (1980-2010)

By Food Ingredient Category, USP Food Fraud Database

Source: USP Food Fraud Database (1980-2010), http://www.foodfraud.org/. As reported in J.C. Moore, J. Spink,

and M. Lipp, “Development and Application of a Database of Food Ingredient Fraud and Economically Motivated

Adulteration from 1980 to 2010,” Journal of Food Science, Vol. 77, Nr. 4, 2012.

Notes: 1980-2010 data: records (1,054); ingredients (250); and references (575).

Figure 3. Leading Reported Types of Fraud, USP Media Records (1980-2010)

By Food Ingredient Category, USP Food Fraud Database

Source: USP Food Fraud Database (1980-2010), http://www.foodfraud.org/. As reported in J.C. Moore, J. Spink,

and M. Lipp, “Development and Application of a Database of Food Ingredient Fraud and Economically Motivated

Adulteration from 1980 to 2010,” Journal of Food Science, Vol. 77, Nr. 4, 2012.

Notes: 1980-2010 data: records (251); ingredients (147); and references (85).

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Figure 4 provides a breakdown by major food ingredient category, according to the databases’

scholarly records following the 2013 database updates. By individual food and food ingredients,

the leading reported types of fraudulent foods were olive oil, milk, saffron, honey, coffee, tea,

fish, clouding agents, and black pepper. Among the new reports examined, many of the mostrepresented products in the database were all among the top fraudulent products reported in the

initial version of the database (such as milk, fish, turmeric, chili powder, and cooking oil);

however, many products were not among the top products, such as shrimp, lemon juice, maple

syrup, and clouding agents.57

Figure 4. Leading Reported Types of Fraud, USP Scholarly Records (1980-2012)

By Food Ingredient Category USP, Food Fraud Database

Source: Data from the USP Food Fraud Database (http://www.foodfraud.org/), 2013 update. As reported by

A.G. Ebert, “The Food Chemicals Codex EMA Activities: The Food Fraud Database – What’s Next?”

Presentation at the USP Workshop of Economically Motivated Adulteration of Food Ingredients and Dietary

Supplements, September 26–27, 2013. Data are for 2011-2012.

Notes: 1980-2012 data: records (1,648) and references (742). 2013 update included 792 additional records and

264 additional references, mostly from 2011-2012.

The 2013 updates to the USP database highlight a number of continuing and emerging issues. As

reported by USP, among the leading reported types of fraud in the updated 2013 database are

“watered-down and urea adulterated fluid milk in India, dilution of milk powder with fillers such

as maltodextrin in South America and replacement of milk fat with vegetable oil in South

America,” as well as “olive oil replaced with other, less-expensive vegetable oils,” and so-called

“gutter oil” (waste oil repurposed as cooking oil) was documented in China.58 The updated USP

57

FDA defines clouding agents as food processing aids “to enhance the appeal or utility of a food or food component,

including clarifying agents ... , catalysts, flocculents, filter aids, and crystallization inhibitors” (21 CFR Part 1700).

58

USP, “Food Fraud Reports Up 60% Since 2010,” January 23, 2013.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

database also documents examples of the dilution or replacement of spices with less-expensive

spices or fillers.

The updated USP database also highlighted increasing reports of seafood fraud, reflecting

previous reports by Oceana and Consumers Union.59 Of particular concern is mislabeled fish sold

in the marketplace that may cause known public health risks. These include the fish escolar

(Lepidocybium flavobrunneum), often labeled as white tuna or butterfish, which is banned in

some countries due to concerns that its high content of waxy esters may cause some types of food

poisoning including gempylotoxism.60 Another is puffer fish (Lagocephalus scleratus), often

mislabeled as monkfish to evade import and other restrictions, and which is known to cause

tetrodotoxin poisonings.61

The updated USP database also highlighted emerging concerns about food fraud involving

“clouding agents.” Specifically, the USP database documents cases involving the fraudulent

addition of the plasticizer Di(2-ethylhexyl) phthalate (DEHP) and other related phthalates as a

substitute for more expensive palm oil or other allowed food ingredients in fruit juices, jams, and

other products. DEHP might also be used in food contact materials, such as seals and packaging.

DEHP is associated with public health risks, including cancer and reproductive concerns. The

scope of the fraud involving clouding agents covers 877 food products from 315 companies, with

206 products exported to a reported 22 countries.62 Given the potential public health concerns,

USP states that clouding agents might be considered the “2011 equivalent to the melamine

scandal involving Chinese milk products from a few years ago.”63

NCFPD EMA Incident Database

As of November 2013, about 300 “incidents” since 1980 are accessible in the National Center for

Food Protection and Defense (NCFPD) EMA Incident Database.64 Previous analyses of the

incidents in the database were based on 137 incidents.65 CRS analysis presented here is based on

information from 302 incidents accessed in the EMA Incident Database, as well as other updated

databases information from NCFPD.

59

Oceana, “Oceana Study Reveals Seafood Fraud Nationwide,” February 2013 (including previous reports in 2011);

and Consumers Union, “Mystery Fish,” Consumer Reports Magazine, December 2011. Similar investigations were also

reported by the Boston Globe newspaper in 2011, http://www.boston.com/business/specials/fish_testing/.

60

FDA’s Bad Bug Book: Foodborne Pathogenic Microorganisms and Natural Toxins Handbook, http://www.fda.gov/

Food/FoodborneIllnessContaminants/CausesOfIllnessBadBugBook/ucm071191.htm. See also K.A. Feldman et al., “A

large outbreak of scombroid fish poisoning associated with eating escolar fish (Lepidocybium flavobrunneum),”

Epidemiol Infect., 133(1):29-33, February 2005.

61

See, for example, J. Field, “Puffer fish poisoning,” J Accid Emerg Med. 15(5): 334–336, September 1998; and G.K.

Isbister, M.C. Kiernan, “Neurotoxic marine poisoning,” Lancet Neurol. 4(4):219-28, April 2005.

62

See, for example, J.A. Tickner, et al., “Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC

medical devices: a critical review,” Am J Ind Med., 39(1):100-11, January 2001; and T.H. Yen et al., “Food safety

involving ingestion of foods and beverages prepared with phthalate-plasticizer-containing clouding agents,” J Formos

Med Assoc., 110(11):671-84, November 2011.

63

USP, “Food Fraud Reports Up 60% Since 2010,” January 23, 2013.

64

Information compiled by CRS from records in the NCFPD EMA Incident Database (database accessed November

14, 2013). Accessible to FoodSHIELD.org members.

65

K. Everstine, J. Spink, and S. Kennedy, “Economically Motivated Adulteration (EMA) of Food: Common

Characteristics of EMA Incidents,” Journal of Food Protection, Vol. 76, Nr. 4, April 2013. The analyses in this article

covered 137 EMA incidents.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

As already noted, an incident is “a documented, isolated occurrence of EMA in a single food

product or group of associated food products occurring within a defined time frame and with a

distinct group of perpetrators.”66

Figure 5 provides a breakdown of EMA incidents by major food ingredient category, according

to the database. By individual food and food ingredients, the leading reported types of fraudulent

foods were (1980 to date) fish and seafood (31%), oils and fats (11%), alcoholic beverages (8%),

meat and meat products (7%), dairy products (6%), and about 5% each for grains and grain

products, and honey and other natural sweeteners.

Figure 6 provides a breakdown of EMA incidents by type of adulteration, as reported in the

database. Cases of EMA due to substitution or dilution accounted for 65% of the incidents,

followed by 13% due to the presence of an unapproved additive. Other incidents are attributable

to counterfeit goods (9%), misbranding (7%), transshipment or masking origin of product (5%),

and the intentional distribution of a potentially hazardous substance (less than 1%), among other

miscellaneous or unknown types of adulteration (less than 1%).

Figure 5. Leading EMA Incidents by Food Ingredient Category (1980 to date)

NCFPD EMA Incident Database

Functional Food

Ingredients

1.3%

Other Beverages

3.6%

Oils, Fats

10.6%

Produce

4.3%

Nutraceutical

1.0%

Meat, Meat

Products

7.3%

Infant Formula

3.6%

Honey, Natural

Sweeteners Grains, Grain

4.6%

Products

5.0%

Spices, Extracts

3.3%

Alcoholic

Beverages

7.9%

Dairy Products

5.6%

Coffee/Tea

Eggs

1.3%

0.7%

Shrimp

0.3%

Fish/Seafood

Products

31.1%

Other

4.6%

Fruit Juices,

Concentrates

3.6%

Source: Compiled by NCFPD CRS from records in the NCFPD EMA Incident Database (database accessed

November 14, 2013) and based on 302 reported incidents. These incidents were also reported by A. Kircher,

“Building Capabilities to Find and Mitigate.” Presentation at the USP Workshop of Economically Motivated

Adulteration of Food Ingredients and Dietary Supplements, September 26–27, 2013.

66

NCFPD news release, “Preventing Economically Motivated Adulteration,” February 4, 2013.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Figure 6. Leading EMA Incidents by Type of Adulteration (1980 to date)

NCFPD EMA Incident Database

Source: Compiled by NCFPD EMA Incident Database (January 6, 2014), based on 306 reported incidents.

Figure 7 provides a breakdown of EMA incidents by location where the product is identified as

being produced, as reported in the database. Among its data, the EMA Incident Database

documents where the fraudulent product was originally produced based on an examination of the

available information. Although the database is not restricted to conditions in the United States

and is broadly reflective of fraud globally, the incidents captured in the database are based on

English-language sources and may not be representative of conditions across all global

commercial markets.

In addition, information in the database by location produced may mask substantial differences

among countries and regions (both globally and within a particular country) in terms of their

ability and dedication to detect fraud. No two countries or regions scrutinize food fraud in the

same way. For example, as noted by researchers at NCFPD,67 the relatively greater number of

reported fish and seafood cases is, in part, attributable to enhanced surveillance and detection by

Florida’s Department of Health. This further reinforces the idea that a possible limitation of either

database is that the available information may at times be more reflective of where research is

being conducted or where resources have been dedicated to detect fraud.

Despite these caveats, the EMA Incidents Database indicates that nearly 30% of the EMA

incidents documented involved products that were produced in the United States. Most of these

were incidents involving mislabeled fish. China and India accounted for another 14% and 13%,

respectively, of the documented EMA incidents. Other countries in Asia accounted for another

5% of the incidents. Combined, the European Union countries accounted for about 15% of the

documented incidents, along with another 3% attributable to other non-EU European countries.

67

Communication between CRS personnel and researchers at University of Minnesota, November 27, 2013.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

About 7% of the incidents were reported to have been produced in the Middle East and Africa

(Figure 7).

Figure 7. Leading EMA Incidents by Location Produced (1980 to date)

NCFPD EMA Incident Database

Source: Compiled by CRS from records in the NCFPD EMA Incident Database (database accessed November

14, 2013) and based on 302 reported incidents.

Differences in Product Ranking among Databases

Reported rankings of foods and food ingredients associated with food fraud based on the USP

Food Fraud Database and the NCFPD EMA Incident Database often differ. As illustrated above,

how these fraudulent foods and food ingredients are ranked will differ depending on which

database is referenced (i.e., whether USP or NCFPD database) and which type of record is

referenced (i.e., whether based on “scholarly” or “media” or EMA “incidents”), and time period.

Rankings also differ within a database. For example, as reported in the 2013 food fraud report by

the European Parliament, the “top ten products that are most at risk of food fraud” using data in

the initial USP database (1980-2010) are identified (in descending order) as olive oil; fish;

organic foods; milk; grains; honey and maple syrup; coffee and tea; spices (such as saffron and

chili powder); wine; and certain fruit juices.68 Comparisons, shown in Table 3, are intended to

illustrate why different reports provide differing rankings of foods associated with fraud. The

prominence of “organic foods” in the European study may be explained by the decision to

distinguish organically certified products separately from all reported foods categorized by food

ingredient category (which include both organic and conventionally produced foods and food

ingredients). The overall prominence of “fish” in the European study may also be explained in

68

European Parliament, Committee on the Environment, Public Health and Food Safety draft report “on the food crisis,

fraud in the food chain and the control thereof,” (2013/2091(INI)).

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

that products may have been ranked across all records and not separated according to “scholarly”

versus “media” records. Although these compilations were derived from the same database, this

example illustrates why some reported compilations differ from others.

Table 3. Leading Reported Types of Food Fraud, Differing Compilations

Various Years and Sources

USP Food Fraud Database: Leading

Ingredient Categories, Accounting for >90%

of Records (Scholarly and Media Combined)

NCFPD EMA Incidents Database:

Leading Ingredient Categories,

Accounting for >90% of Records (Media)

EU Report:

“Top ten”

products at risk

of food fraud

1980-2010

1980-2012

1980-2010

1980-2012

1980-2010

(a)

(b)

(c)

(d)

(e)

Oils

Oils

Other miscellaneous

Fish, seafood

Olive oil

Spices

Spices

Fish and seafood

Oils and fats

Fish

Milk

Milk

Dairy products

Alcoholic beverages

Organic foods

Fruit juice, concentrate

Other miscellaneous

Fruit juices

Meat, meat products

Milk

Natural flavorings

Sweeteners

Oils and fats

Dairy products

Grains

Sweeteners

Fruit juice, concentrate

Grain products

Grains, grain products

Honey, maple syrup

Other miscellaneous

Natural flavorings

Honey

Honey, sweeteners

Coffee, tea

Cereals, grains, pulses

Seafood (incl. fish)

Spices and extracts

Produce

Spices

Seafood

Cereals, grains, pulses

Wine

Fruit juice,

concentrate

Wine

Dairy products

Wines, musts, spirits

Infant formula

Spices, extracts

Fruit juices

Wines, spirits, vinegars

Dairy products

Plant-based proteins

Other beverages (nonalcoholic, not juice)

Protein-based ingred.

Functional food ingred.

Preservatives

Gums

Meats

Sources:

(a), (b) Compiled by Jeff Moore, USP, December 22, 2013.

(c) NCFPD presentation, USP's Food Ingredients Intentional Adulterants Expert Panel, Meeting #3, October 23,

2012. Provided by Jeff Moore, USP, December 2013.

(d) Compiled by Karen Everstine, NCFPD, January 2014.

(e) As reported in European Parliament, Public Health and Food Safety draft report “on the food crisis, fraud in

the food chain and the control thereof,” (2013/2091(INI)), citing information obtained from the USP database.

Notes: Data from the USP Food Fraud Database and the NCFPD EMA Incident Database.

a.

Clouding agents are used as food processing aids (21 CFR Part 170, Food Additives).

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

Federal Activities Involving Food Fraud

In the United States, no single federal agency and no single U.S. law or statute directly addresses

food fraud or “economically motivated adulteration” of food and food ingredients. Instead, food

fraud and intentional adulteration of food is broadly addressed through food safety authorities and

border protection and import authorities and activities. Accordingly, FDA and USDA are the

principle federal agencies that are working to protect the food supply from food safety risks,

including both unintentionally and intentionally introduced contamination, in conjunction with

enforcement of FDA and USDA laws by the U.S. Department of Homeland Security (DHS) as

part of its border inspections.

FDA and USDA are the leading food safety regulatory authorities. FDA, an agency of the

Department of Health and Human Services (HHS), is responsible for ensuring the safety of all

domestic and imported food products (except for most meats and poultry). USDA’s Food Safety

and Inspection Service (FSIS) regulates most meat and poultry and some egg products. However,

the boundaries between the two agencies’ jurisdictions are complex and often at odds with

commonplace distinctions among food groups.69 The laws that grant these and other federal

agencies authority over foods and food ingredients also provide these agencies with the authority

to govern the labeling of these products, which might also act as a further deterrent to food fraud

in some cases.70

Other federal agencies also provide product quality standards and grading, including FDA,

USDA’s Agricultural Marketing Service (AMS), and the National Marine Fisheries Service

(NMFS), which is part of the U.S. Department of Commerce’s National Oceanic and Atmospheric

Administration (NOAA). State and local food safety authorities assist the federal agencies with

inspection, outbreak response, and other food safety functions, among other functions. Import

security measures by FDA and USDA are conducted in conjunction with border inspections by

the Customs and Border Protection (CBP), which is part of DHS.

Other agencies also have played a role in food fraud prevention. The U.S. Department of Justice

(DOJ) has actively pursued a number of food fraud cases in the U.S. courts involving a range of

products and resulting in criminal convictions in some cases.71 In the high-profile case involving

the Peanut Corporation of America, company executives were indicted in early 2013 with federal

criminal charges that included fraud, conspiracy, and the introduction of adulterated food into

interstate commerce with the intent to defraud or mislead.72 USDA’s National Organic Program

(NOP) has taken numerous enforcement actions against companies involving false labeling

69

Jurisdiction issues are addressed in a Memorandum of Understanding (MOU) between FSIS and FDA (MOU 22599-2001), http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/

DomesticMOUs/ucm117094.htm. Other information is in CRS Report RS22600, The Federal Food Safety System: A

Primer.

70

“A Guide to federal Food Labeling Requirements for meat, Poultry, and Egg Products,” prepared for USDA Food

Safety and Inspection Service by Hogan & Hartson, LLP, August, 2007, http://www.fsis.usda.gov/wps/wcm/connect/

f4af7c74-2b9f-4484-bb16-fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.

71

See, for example, more recent cases involving olive oil and honey as described in A. Healy, “Lawsuit over olive oil

labeling will go to trial,” Food Chemical News, November 22, 2013; and DOJ press release, “Texas Honey Broker

Sentenced to Three Years in Prison for Avoiding $37.9 Million in Tariffs on Chinese-Origin Honey,” November 14,

2013.

72

DOJ press release, “Former Officials and Broker of Peanut Corporation of America Indicted Related to SalmonellaTainted Peanut Products,” February 21, 2013.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

claims on organic foods, and a number of advocacy groups have filed lawsuits involving concerns

about the validity of organic claims. NOAA also has conducted federal investigations and taken

enforcement actions involving seafood labeling and misbranding.73

The text box below provides a comparison of FDA and USDA responsibilities for food safety and

regulations, and responsibilities of other federal agencies.

Comparison of Selected Agency Responsibilities for Food Safety and Regulation

Agency

Responsibility

Food and Drug Administration (FDA)

• Food (but not meat)

• Dietary supplements

• Bottled water

• Seafood

• Wild game ( “ exotic ” meat)

• Eggs in the shell

U.S. Department of Agriculture (USDA)

• Grading of raw fruit and vegetables

• Meat and Poultry

• Eggs, processing and grading

• Certifying organic production

National Oceanic and Atmospheric Administration

• Grading of fish and seafood

Environmental Protection Agency (EPA)

• Drinking water

• Pesticide residues

Customs and Border Protection (CBP)

• Front-line enforcement and referral

Department of Justice (DOJ)

• Law enforcement

Federal Trade Commission (FTC)

• Advertising

Alcohol and Tobacco Tax and Trade Bureau (TTB)

• Alcohol

Source: CRS, as adapted from N. D. Fortin, Introduction to Food Regulation in the United States, Part 1 (Introductory

Chapters), May 2008.

The federal government also has helped fund some of the ongoing research. These efforts were

developed with the support of funding from DHS, FDA, and USDA.74 In addition, FDA is

developing a number of tools and guidance materials for the food industry to address intentional

adulteration as part of its food defense strategy.75

73

See, for example, National Oceanic and Atmospheric Administration (NOAA) press release, “NOAA Investigations

Into Mislabeling Seafood Protects Consumers and Fishermen,” February 4, 2011.

74

Comments by J. Spink, MSU, November 12, 2013, as part of the massive open online course (MOOC) on food fraud.

75

For a listing of programs, such as Food Defense Plan Builder and Food Related Emergency Exercise Bundle (FREEB), see FDA, “Tools and Educational Materials,” http://www.fda.gov/Food/FoodDefense/ToolsEducationalMaterials/.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

The U.S. Government Accountability Office (GAO) has conducted a series of investigations into

food fraud cases, including fruit juice76 and seafood.77 GAO’s most recent report addressed a

wider range of fraudulent foods and issued more broad-based recommendations.78 GAO’s

recommendations involving food fraud addressed the need for improved cross-agency

communication and coordination and enhanced information sharing and transparency. Other

recommendations called for the creation of an information clearinghouse and the need for

increased oversight and inspections, and increased risk-based testing, in some cases.

A 2013 report by the U.S. International Trade Commission (USITC) cited research indicating that

current standards for extra virgin olive oil are widely unenforced and result in a wide range of

olive oil qualities to be labeled as “extra virgin” oil. The study further concluded that this may

lead to adulterated and mislabeled product, which could further weaken the competitiveness of

U.S.-produced olive oil in the domestic market.79

In Europe, in the wake of the horsemeat scandal, some countries have debated the need for

tougher laws to protect consumers against food fraud. The European Parliament released its draft

report regarding food fraud in October 2013, calling for increased enforcement and oversight

regarding fraud prevention through the food supply chain.80

HHS, Food and Drug Administration

Laws governing FDA’s authority over both unintentional and intentional adulteration of both

domestic and imported food—namely, the Federal Food, Drug, and Cosmetic Act—provide the

agency with some of the necessary tools to pursue activities that ensure against fraud of foods and

food ingredients under its jurisdiction.

Food Safety Authorities

FDA has primary responsibility for the safety of most—about 80%-90%—of all U.S. domestic

and imported foods.81 The FDA is responsible for ensuring that all domestic and imported food

products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately

labeled. Examples of FDA-regulated foods are produce, dairy products, and processed foods.

76

GAO, Fruit Juice Adulteration, Detection is Difficult and Enhanced Efforts Would be Costly, GAO/RCED-96-18,

November 1995.

77

GAO, Seafood Fraud, FDA Program Changes and Better Collaboration among Key Federal Agencies Could

Improve Detection and Prevention, GAO-09-258, February 2009.

78

GAO, Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health,

GAO-12-46, October 2011.

79

USITC, Olive Oil: Conditions of Competition between U.S. and Major Foreign Supplier Industries,” Inv. 332-537,

August 2013.

80

European Parliament, Committee on the Environment, Public Health and Food Safety draft report “on the food crisis,

fraud in the food chain and the control thereof,” (2013/2091(INI)).

81

Estimated by backing out the reported 10%-20% of foods under USDA’s jurisdiction. The 20% estimate is based on

information reported by GAO in “Revamping Oversight of Food Safety,” prepared for the 2009 Congressional and

Presidential Transition, and appears to represent proportions of total spending for food consumed at home. The 10%

estimate is based on data from USDA-ERS on U.S. per capita food consumption at http://www.ers.usda.gov/data/

foodconsumption/. See also DHS, “National Infrastructure Protection Plan: Agriculture and Food Sector Snapshot,”

http://www.dhs.gov/food-and-agriculture-sector.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

FDA also has oversight of all seafood and shellfish products, and most fish products.82 FDA has

jurisdiction over meats from animals or birds that are not under the regulatory jurisdiction of

FSIS. FDA shares some responsibility for the safety of eggs with FSIS. FDA has jurisdiction over

establishments that sell or serve eggs or use them as an ingredient in their products.

As described in a Memorandum of Understanding between FDA and FSIS:83

FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), the Fair

Packaging and Labeling Act (15 U.S.C. 1451 et seq.), and parts of the Egg Products Inspection

Act. In carrying out its responsibilities under these acts, FDA conducts inspections of

establishments that manufacture, process, pack, or hold foods, with the exception of certain

establishments that are regulated exclusively by FSIS. FDA also inspects vehicles and other

conveyances, such as boats, trains, and airplanes, in which foods are transported or held in

interstate commerce.

“Prohibited” Acts

FDA’s food safety authorities rest primarily with the Federal Food, Drug, and Cosmetic Act

(FFDCA), as amended, requiring that foods be safe, wholesome, and accurately labeled.

“Prohibited” acts are listed in FFDCA Section 301 (21 U.S.C. §331). Along with other specified

prohibited acts, the law provides that introducing adulterated or misbranded food into commerce;

adulterating or misbranding food that is in commerce; or the receipt and delivery of adulterated or

misbranded food in commerce is prohibited. As such, under FFDCA, two of the basic statutory

components are “adulteration” and “misbranding.”

FDA-regulated foods may be deemed adulterated or misbranded for a variety of statutorily

prescribed reasons. For example, food may be deemed adulterated if it contains an added

poisonous or deleterious substance or an unsafe food additive or if the food was prepared, packed,

or held under unsanitary conditions whereby it may have become contaminated or may have been

rendered injurious to health. Persons who violate FFDCA by, for example, introducing an

adulterated or misbranded product into interstate commerce are subject to criminal and civil

penalties.

According to FFDCA Section 402(a) (21 U.S.C. §342[a]), a food shall be deemed to be

“adulterated” (and therefore prohibited) if it bears or contains or has any added “poisonous or

deleterious substance” which may be “injurious to health” or is considered unsafe under the law,

unless specifically exempted. Adulteration also covers food that consists of a “filthy, putrid, or

decomposed substance,” or if it is otherwise unfit for food or “if it has been prepared, packed, or

held under insanitary conditions,” or if it otherwise poses a risk to consumer health.

Perhaps more specific to food fraud, although generally less noted,84 FFDCA Section 402(b) (21

U.S.C. §342[b]), are foods deemed to be adulterated given the “absence, substitution, or addition

of constituents” including:85

82

FSIS was authorized to inspect farmed catfish products under a 2008 farm bill provision (P.L. 110-246, §11016), but

has not yet been implemented.

83

MOU 225-99-2001, http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/

DomesticMOUs/ucm117094.htm.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if

any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has

been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed

therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear

better or of greater value than it is.

Accordingly, a food may be deemed adulterated if it is missing a “valuable constituent” or if

substances have been substituted wholly or in part or where damage or inferiority has been

concealed in any matter, including cases where substances are added to “increase its bulk or

weight” or make it appear to be higher quality.

Under FFDCA, introducing misbranded food into commerce, misbranding food that is in

commerce, or the receipt and delivery of misbranded food in commerce is also prohibited.

FFDCA Section 403 (21 U.S.C. §343) defines a number of conditions under which a food would

be deemed to be misbranded. A food is deemed misbranded if it has a false or misleading label, is

offered for sale under another name, is an imitation of another food, or is in a “misleading

container” that is “made, formed, or filled to be misleading,” among other types of

misrepresentative packing or labeling. Similar to the definition of adulteration, numerous specific

types of misbranding are also defined. These include, among others, failure to disclose specific

additives or allergens in the food, and failure to provide required nutritional information. (In

addition to FFDCA, FDA has regulatory authority under the Fair Packaging and Labeling Act

[FPLA, 15 U.S.C. §1451 et seq.]. FPLA establishes requirements for package labels of all

consumer goods, including most foods.)

Violating the misbranding or adulteration provisions of FFDCA may invoke criminal penalties

and/or product seizures. Under FFDCA Section 303 (21 U.S.C. §333), in general, any person who

commits a prohibited act under FFDCA may be subject to civil or criminal penalties, including

imprisonment, fines, or both. Criminal penalties provided for in FFDCA are adjusted by 18

U.S.C. Sections 3559 and 3571. Certain exceptions may be made, including for the misbranding

of foods. FFDCA Section 304 (21 U.S.C. §334) also provides that FDA may order the

administrative detention of foods, if a food is suspected to be adulterated or misbranded based on

an inspection, examination, or investigation.

Although fraudulent activities may be illegal and enforceable under the FFDCA, FDA might not

take enforcement in some cases. Practically speaking, it may not be possible for FDA and DOJ to

prosecute every instance of food fraud given each agency’s myriad other responsibilities and

limited personnel and resources. Also, oftentimes inadequate evidence exists to effectively

enforce against all alleged or suspected cases of fraud.

Other Agency Authorities and Activities

FFDCA Section 415 (21 U.S.C. §350d) requires FDA to oversee the registration of both domestic

and foreign food facilities, which was part of the Public Health Security and Bioterrorism

(...continued)

84

See, for example, R. Carvajal, “USP, Food Fraud, and FSMA, FDA Law Blog, April 16, 2012,

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/usp-food-fraud-and-fsma.html.

85

FFDCA §402(b) [21 U.S.C. §342(b)].

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Preparedness and Response Act of 2002 (“Bioterrorism Act”).86 Under the act, facilities that

manufacture, process, pack, or hold food for human or animal consumption in the United States

must be registered with FDA.87 Domestic facilities must register whether or not food from the

facility enters interstate commerce. Foreign facilities must register unless food from that facility

undergoes further processing (including packaging) by another foreign facility before the food is

exported to the United States. FDA also must be given advance notice on shipments of imported

food. These registration and prior notification requirements might act as a further deterrent to

food fraud in some cases.

Table 4 shows available data on the total number of registered domestic and foreign food

facilities. The number of registered food facilities—both domestic and foreign—more than

doubled from 2004 to 2012, the most recent available data.88 Of the total number of registered

facilities with FDA in 2012 (nearly 450,000), a reported 171,552 were domestic facilities and

278,307 were foreign facilities (Table 4).

Table 4. Registered Food Facilities, FY2004-FY2012

FY04

FY05

FY06

FY07

FY08

FY09

FY10

FY11

FY12

All Registered

Food Facilities

214,253

253,006

288,092

323,590

356,287

391,281

418,593

438,305

449,859

Domestic

92,719

104,555

115,902

129,345

141,703

154,883

166,160

167,033

171,552

Foreign

121,534

148,451

172,190

194,245

214,584

236,398

252,433

271,272

278,307

Source: Compiled by CRS from data on registered domestic and foreign facilities under FFDCA §415 (21 U.S.C.

§350d); FDA’s annual reporting requirements of these data are at FFDCA §1003 (21 U.S.C. §393).

Notes: Number of registrants as of November 18, 2013. Available FY2012 data are from FDA, “Registration

Statistics,” http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm. FY2004-2011

data are FDA Office of Legislation (September 22, 2010, and May 7, 2012, communication); FDA, “Annual Report

on Food Facilities, Food Imports, and FDA Foreign Offices” for 2011 and 2012, http://www.fda.gov/Food/

GuidanceRegulation/FSMA/ucm250569.htm; and HHS OIG, FDA Inspections of Domestic Food Facilities (OEI-02-0800080).

Finally, FFDCA also broadly provides for FDA to establish voluntary food quality and grading

standards, and product standards of identity (FFDCA §401 [21 U.S.C. §341]). Although not

regulatory in nature, and not intended to address potential food safety or food fraud concerns,

food quality and grading standards provide a product benchmark for certain foods or food

ingredients. Specifically, FFDCA directs FDA to establish definitions and standards for food to

“promote honesty and fair dealing” for the benefit of consumers.89 Under the statute, FDA is

authorized to establish regulations “for any food ..., a reasonable definition and standard of

identity, a reasonable standard of quality, and reasonable standards of fill” of the container for any

food. FDA has established roughly 300 identity standards in 20 categories of food, consisting of a

range of processed foods and meat, dairy, and seafood products, as well as preserved and

86

P.L. 107-188.

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food

for consumption in the U.S. are required to register the facility with FDA. See FDA, “Registration of Food Facilities,”

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm.

88

FDA, “Registration Statistics,” http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm.

89

Regulations are 21 CFR Parts 130-169. 21 CFR 130 covers general requirements.

87

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

processed fruit and vegetable products and juices. Standards of identity cover mostly processed

and value-added foods for a wide range of FDA-regulated food products.

Potential Role of the Food Safety Modernization Act

FDA has taken a series of internal actions to address intentional adulteration, including EMA.90 In

April 2009, FDA conducted a public meeting to raise awareness and solicit public input regarding

economically motivated adulteration of FDA-regulated products. FDA also established, in

September 2011, an internal workgroup comprised of staff from all FDA product centers

(covering both food and non-food products regulated by FDA), FDA’s Office of Regulatory

Affairs (ORA),91 and the Office of the Commissioner. The workgroup includes risk managers,

economists, regulatory counsel, policy analysts, and scientists, and uses a multidisciplinary

collaborative approach to capitalize on commonalities among FDA’s product centers.92 Part of the

workgroup’s mission is to address recommendations regarding EMA from the U.S. Government

Accountability Office (GAO) that called for improved cross-agency communication and

enhanced information sharing and transparency with stakeholders, including the regulated

community.93 FDA reportedly is also considering another GAO recommendation that would

establish an information clearinghouse so stakeholders could share information about products

that may be susceptible to economic adulteration.94

The 111th Congress amended FFDCA by passing a comprehensive food safety law, the Food

Safety Modernization Act (FSMA, P.L. 111-353).95 FSMA aims to prevent both intentional and

unintentional introduced contamination of foods through a variety of strategies to prevent food

contamination and through enhanced regulatory authorities. FDA has not yet implemented many

of the law’s major provisions.96 FSMA provides for increased food risk protection by creating

mechanisms whereby food companies are required to identify and implement preventive controls

to ensure adulterated products are not sold and then share their plan with the FDA to ensure

compliance with good manufacturing practices. Having such controls in place would also allow

companies to consider their responsibility regarding potentially adulterated foods involving the

“absence, substitution, or addition of constituents.” Some speculate that provisions under FSMA

will likely result in increased detection and prevention of adulterated foods by the food

companies, both under FFDCA Section 402(a) (21 U.S.C. §342[a]) and FFDCA Section 402(b)

(21 U.S.C. §342[b]).97 Since FDA could not possibly enforce every instance of food adulteration,

90

For an informative overview of how EMA activities have evolved FDA, see J. Spink, “Economically Motivated

Adulteration: Another Dimension of the ‘Expanding Umbrella of Food Defense,’” Food Safety Magazine,

October/November 2013.

91

ORA is the lead office for all agency field activities, and inspects regulated products and manufacturers, conducts

sample analyses of regulated products and reviews imported products offered for entry into the United States.

92

J. Thomas, “FDA Workgroup on Economically Motivated Adulteration,” Presentation at the USP Workshop of

Economically Motivated Adulteration of Food Ingredients and Dietary Supplements, September 26–27, 2013.

93

GAO, Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health,

October 2011, GAO-12-46.

94

J. Murphy, “FDA Struggles with FSMA-Required Role in Combating Food Fraud,” Food Chemical News, May 10,

2013.

95

P.L. 111-353. For information, see CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353).

96

FDA’s rulemaking documents are available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/

ucm253380.htm.

97

See, for example, R. Carvajal, “USP, Food Fraud, and FSMA, FDA Law Blog, April 16, 2012,

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/usp-food-fraud-and-fsma.html.

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such industry controls will be instrumental in helping to combat future adulteration before it ever

reaches the marketplace.

FSMA does not directly address EMA; however, some of its provisions may have application to

EMA even though some of these provisions may have originated as part of an overall food

defense strategy. These FSMA provisions include:

•

FSMA Section 103 (Hazard Analysis and Risk-Based Preventive Controls).98

FSMA requires preventive controls for human food by domestic and foreign

firms that manufacture, process, pack, or hold human food. Among the

requirements are written plans that identify hazards, specify the steps that will be

put in place to minimize or prevent those hazards, identify monitoring

procedures, and record monitoring results and specify what actions will be taken

to correct problems that arise. These regulations would address, among other

things, “hazards that occur naturally, may be unintentionally introduced, or may

be intentionally introduced, including by acts of terrorism.”

As part of its proposed rule published in January 2013, FDA states that

intentional hazards, such as EMA, might require separate agency action. As part

of the proposed rulemaking, FDA also has requested public comment on if and

how it should address EMA:99

FDA tentatively concludes that intentional hazards, which are not addressed in

traditional HACCP100 or other food safety systems, likely will require different kinds

of controls and would be best addressed in a separate rulemaking ... We request

comment on whether to include potential hazards that may be intentionally introduced

for economic reasons ... [and] on when an economically motivated adulterant can be

considered reasonably likely to occur.

•

FSMA Section 106 (Protection Against Intentional Adulteration). FSMA

requires FDA to issue regulations to protect against the intentional adulteration of

food, such as “specifying appropriate science-based mitigation strategies or

measures to prepare and protect the food supply chain from intentional

adulteration at specific vulnerable points.”101 The proposal for this rulemaking

was published in December 2013, and is the first time FDA has proposed a

regulatory approach for preventing intentional adulteration of food.102

•

FSMA Section 108 (National Agriculture and Food Defense Strategy). FSMA

requires that the Secretaries of Health and Human Services and Agriculture

develop a National Agriculture and Food Defense Strategy, implementation plan,

98

For more information, see FDA, “FSMA Proposed Rule for Preventive Controls for Human Food Current Good

Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,”

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm (docket#: FDA-2011-N-0920).

99

78 Federal Register 11: 3695. January 16, 2013.

100

HACCP refers to “Hazard Analysis & Critical Control Points” and is defined by FDA as a management system to

address food safety through the analysis and control of biological, chemical, and physical hazards from raw material

production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

101

FDA, “Frequently Asked Questions,” http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm.

102

For more information, see FDA, “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration,”

December 2013, http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm.

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Food Fraud and “Economically Motivated Adulteration” of Food and Food Ingredients

and research agenda. This strategy and the accompanying documents have not

yet been published.103

•

FSMA Title 3 (Improving the Safety of Imported Food). To the extent that

food fraud may be attributable to foods imported into the United States, FSMA

provides for a series of requirements to ensure the safety of imported foods.

Tightened import requirements may act to limit future fraud, or lend greater

credibility to foods and food ingredients that are imported under these

requirements. FSMA also recognizes “third party” audits or certifications, and

several such entities have already started to address food fraud both in term of

identifying terms or assessing implementation actions such as vulnerability

assessments.104 FDA’s proposed rules were published in July 2013.105

•

FSMA Section 402 (Employee Protections). FSMA expands protections for

employees (whistleblowers) who provide information relating to FFDCA

violations, such as testifying, assisting, or participating in a proceeding on such a

violation, refusing to participate in an activity that may violate FFDCA.

•

FSMA Section 201(b) (Annual Report Regarding Food). FSMA requires FDA

to submit an annual to report to Congress, covering efforts to coordinate and

cooperate with other federal agencies with responsibilities for food inspections,

and report information regarding facility inspections and facility registrations,

among other things.106

FDA has been working with other federal agencies to coordinate and cooperate on food safety

activities. According to FDA’s most recent report on these types of activities, for example, FDA

and the Department of Defense have “information-sharing networks and processes on facility

audits and inspections, recalls, import alerts, laboratory findings and methods, and other food

protection procedures.”107 FDA officials have indicated that obtaining additional data and

information would likely require enhanced public and private partnerships.108

Import Authorities

Import security measures by FDA are conducted in conjunction with border inspections by

CBP.109 As part of this responsibility, importers of foreign food are responsible for verifying that

103

For more information, see FDA, FSMA Reports and Studies, http://www.fda.gov/Food/GuidanceRegulation/FSMA/

ucm271961.htm.

104

For more information, see J. Spink, C.T. Elliott, and K.P. Swoffer, “Defining Food Fraud Prevention to Align Food

Science and Technology Resources,” Food Science & Technology Journal, Vol. 27, Nr. 4, December 2013.

105

For more information, see FDA, “Food Supplier Verification Programs (FSVP) for Importers of Food for Humans

and Animals,” July 2013 (docket# FDA-2011-N-01436); and “Accreditation of Third-Party Auditors/Certification

Bodies to Conduct Food Safety Audits and to Issue Certifications,” July 2013 (docket# FDA-2011-N-01468); and

“Information Required in Prior Notice of Imported Food,” May 2013 (docket# FDA-2011-N-017911), available at

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.

106

Reports required under FSMA are available at http://www.fda.gov/food/guidanceregulation/fsma/ucm271961.htm.

107

FDA, “2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices,” August 2012,

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm315486.htm

108

Comments attributed to FDA Deputy Commissioner for Foods and Veterinary Medicine, Mike Taylor, reported by

J. Murphy, “FDA Struggles with FSMA-Required Role in Combating Food Fraud,” Food Chemical News, May 10,

2013.

109

FDA commissions CBP to assist FDA with examinations and investigations related to prior notice requirements for

(continued...)

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the products obtained from foreign processors are in compliance with U.S. laws. FDA’s

surveillance of imported foods consists of reviews of prior notice data, reviews of customs entry

forms, physical or sensory analysis, sample collections for laboratory analysis, and detention

without physical examination.

As required by the Bioterrorism Act, FDA must have received a notice for articles of food being

imported or offered for import into the United States, prior to importation (FFDCA §801(m) [21

U.S.C. §381(m)]). Prior notice is required to enable the food to be inspected at U.S. ports of entry,

and FDA must refuse admission to food imported or offered for import if the notice was not

submitted or if the notice was deficient. Additionally, FDA may hold food at the port of entry if it

is imported or offered for import by a person who was debarred under FFDCA or if it was

imported or offered for import from a foreign facility that has not registered with the FDA. FDA

screens the electronic shipping records of all imported food products before they enter the United

States. From these records, the agency selects products for physical examination and/or testing to

determine whether they contain adulterants.

Under FFDCA Section 801 (21 U.S.C. §381), FDA has the authority to refuse entry of any food

import if it appears to be adulterated, misbranded, or in violation of U.S. law. In such cases,

FFDCA generally provides that such a food article must be refused admission into the United

States, with few exceptions, “if it appears from the examination of such samples or otherwise”

that it has been “manufactured, processed, or packed under insanitary conditions,” or it is

“forbidden or restricted in sale in the country in which it was produced or from which it was

exported,” or it is “prohibited from introduction or delivery for introduction into interstate

commerce under section 301(ll)” (FFDCA §801(a)).

FDA actions on suspect imported products may be implemented through FDA’s “Import Alerts.”

An alert can be issued for an import from a manufacturer, shipper, grower, geographical area, or

country. An active import alert provides a signal to border inspectors to look more closely at a

particular product, or a range of products from a particular producer, shipper, or importer. If the

problem or condition exists on a wide scale, FDA may be instructed to detain all products of a

certain kind coming from a country or a region of a country. Products that may be subject to

refusal based on existing evidence (such as a history of violations) can be detained at the border

and refused admission into U.S. commerce unless the importer is able to demonstrate that the

products are in compliance.110 Import alerts may allow U.S. authorities (typically the U.S.

Treasury has delegated its authority via DHS to the Customs and Border Protection) to detain,

without physically examining, products that either have or potentially could violate FFDCA.111

Detention without physical examination (DWPE), formerly known as “automatic detention,” was

developed to address recurrent violations.112

(...continued)

imported goods (21 U.S.C. §381(m)) at ports and other facilities and locations subject to CBP jurisdiction, under MOU

225-04-4001 (http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/

DomesticMOUs/ucm115145.htm).

110

If a shipment is refused admission, the importer may introduce evidence within 10 days to avoid the appearance of a

violation. During that time, the product is held at a warehouse or with the importer and cannot be distributed. If the

shipment is not proven to be safe, it must be destroyed or exported within 90 days.

111

FDA, “Import Alerts Guard Against Unsafe Products,” August 25, 2011. The database is at http://www.fda.gov/

Forindustry/ImportProgram/ImportAlerts/default.htm.

112

FDA, “Detention without Physical Examination,” http://www.fda.gov/ICECI/ComplianceManuals/

RegulatoryProceduresManual/ucm179271.htm; and Linda Horton, “U.S. FDA Authority over Imports,”

(continued...)

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In FY2011, FDA reports that it physically examined (conducted field exams or analyzed samples

of U.S. food imports under its jurisdiction) 243,400 food and feed import lines.113 This was out of

a total of 10.4 million food import lines for FY2011.114 Hence, FDA physically examined 2.3% of

all shipments. As noted by FDA, this physical examination was in addition to FDA’s electronic

screening of all import lines against a variety of risk criteria. As part of FDA’s screening process,

it implemented its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting

(PREDICT) information technology system that helps target high-risk products before they enter

the United States. Widely cited previous estimates of FDA food safety inspections of foreign

facilities indicate that the rate of such inspections was even lower: GAO reported that, in 2000,

FDA inspections covered only about 1% of the food imported under its jurisdiction.115 Changes to

FDA’s import regime under FSMA are expected to further address some of these concerns.

USDA, Food Safety and Inspection Service

Similar to laws governing FDA that may be broadly construed to provide the agency’s authority

over both unintentional and intentional adulteration of the food supply, the principal food safety

laws governing USDA—namely, the Federal Meat Inspection Act and the Poultry Products

Inspection Act—might likewise allow USDA to pursue activities to ensure against fraud of meat

and poultry products under USDA’s jurisdiction.

Food Safety Authorities

Excluding FDA-regulated foods, FSIS is responsible for the safety of the remaining roughly 10%20% of foods covered by the U.S. food safety system, including meat and poultry and some egg

products.116 As described in a Memorandum of Understanding between FDA and FSIS, FSIS’s

jurisdiction is as follows:117

FSIS is responsible for implementing and enforcing the Federal Meat Inspection Act (21 U.S.C.

601, et seq.), the Poultry Products Inspection Act (21 U.S.C. 451, et seq.), and parts of the Egg

Products Inspection Act (21 U.S.C. 1031, et seq.). In carrying out its responsibilities under these

acts, FSIS places inspectors in meat and poultry slaughterhouses and in meat, poultry, and egg

processing plants. FSIS also conducts inspections of warehouses, transporters, retail stores,

restaurants, and other places where meat, poultry, and egg products are handled and stored. In

addition, FSIS conducts voluntary inspections under the Agriculture Marketing Act (7 U.S.C.

1621, et seq.).

(...continued)

http://www.hoganlovells.com/files/Publication/a279dfd1-c81e-464e-a4f0-b26b6da16f29/Presentation/

PublicationAttachment/4511545b-3ab8-4982-a2f6-ccfa2990c0a8/Horton.pdf.

113

An entry line refers to a unique shipment.

114

FDA, “2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices,” August 2012,

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm315486.htm

115

GAO, Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001, http://www.gao.gov/

new.items/d0247t.pdf.

116

For more information, see CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.

For more direct assistance, contact (name redacted), Analyst in Agricultural Policy ([redacted]@crs.loc.gov, 7-....)

.

117

MOU 225-99-2001, http://www.fda.gov/AboutFDA/PartnershipsCollaborations/

MemorandaofUnderstandingMOUs/DomesticMOUs/ucm117094.htm.

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The Federal Meat Inspection Act (FMIA) of 1906, as amended, requires USDA to inspect all

cattle, sheep, swine, goats, horses, mules, and other equines slaughtered and processed for human

consumption. The Poultry Products Inspection Act (PPIA) of 1957, as amended, gives USDA the

authority to inspect poultry meat. The PPIA mandates USDA inspection of any domesticated

birds (chickens, turkeys, ducks, geese, guineas, ratites [ostrich, emu, and rhea], and squab

[pigeons up to one month old]) intended for use as human food. The Egg Products Inspection Act,

as amended, provides USDA authority to inspect liquid, frozen, and dried egg products. Each of

these laws also contain provisions governing USDA’s authority to label food products under its

jurisdiction.118

Under the authority of the Agricultural Marketing Act of 1946 as amended, USDA’s FSIS may

provide voluntary inspection for buffalo, antelope, reindeer, elk, migratory waterfowl, game

birds, and rabbits. This type of inspection is performed by FSIS on a fee-for-service basis.

However, these meat and poultry species are still within the purview of FDA under FFDCA,

whether or not inspected under the voluntary FSIS program. FDA has jurisdiction over meat

products from such species in interstate commerce, even if they bear the USDA inspection mark.

FDA also has jurisdiction over shell eggs. In addition, the 2008 farm bill requires that FSIS

inspect and grade farmed catfish products.119

Meat and poultry animals and products undergo continuous (i.e., 100%) inspection, which may in

turn act as a deterrent to fraud in some cases. FSIS inspects all meat and poultry animals to look

for signs of disease, contamination, and other abnormal conditions, both before and after

slaughter (“antemortem” and “postmortem,” respectively), on a continuous basis—meaning that

no animal may be slaughtered and dressed unless an inspector has examined it. One or more

federal inspectors are on the line during all hours the plant is operating. Processing plants visited

once every day by an FSIS inspector are considered to be under continuous inspection in keeping

with the laws. Inspectors monitor operations, check sanitary conditions, examine ingredient levels

and packaging, review records, verify food safety plans,120 and conduct statistical sampling and

testing of products for pathogens and residues during their inspections.121

FSIS is responsible for certifying that foreign meat and poultry plants are operating under an

inspection system equivalent to the U.S. system before they can export their product to the United

States.122 Meat and poultry imports are 100% visually inspected (process-based, documentation,

labeling), although physical inspections of imports may be more random. FSIS conducts

evaluations of foreign meat safety programs and visits establishments to determine whether they

are providing a level of safety equivalent to that of U.S. safeguards. No foreign plant can ship

meat or poultry to the United States unless its country has received such an FSIS determination.

118

“A Guide to federal Food Labeling Requirements for meat, Poultry, and Egg Products,” prepared for USDA Food

Safety and Inspection Service by Hogan & Hartson, LLP, August, 2007, http://www.fsis.usda.gov/wps/wcm/connect/

f4af7c74-2b9f-4484-bb16-fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.

119

P.L. 110-246, §11016 (Inspection and Grading). USDA has not yet finished its catfish inspection rule (76 Federal

Register 10434, February 24, 2011), and will inspect catfish facilities when the rule is finalized.

120

In a Hazard Analysis and Critical Control Point (HACCP) plan a facility must identify each point in its processes

where contamination could occur (“critical control point”) and have a plan to control it, as well as document and

maintain records.

121

For more information, see CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.

122

For information, see FSIS, “FSIS Import Procedures for Meat, Poultry & Egg Products,” http://www.fsis.usda.gov/.

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About 1,100 of the establishments under the jurisdiction of FSIS either slaughter, or slaughter and

process livestock, or poultry.123 More than 4,000 facilities only process meat and poultry, and

about 80 process egg products. In addition to inspecting domestic meat, poultry, and egg

establishments, FSIS also performs re-inspections of imported meat, poultry, and egg products at

about 140 import re-inspection facilities.

“Prohibited” Acts

FMIA and PPIA also authorize USDA to regulate labeling and packaging of meat, poultry, or

processed parts to prevent false or misleading marks, labels, or containers (FMIA, 21 U.S.C. §607

and PPIA, 21 U.S.C. §457).124 Similar to FFDCA, both FMIA and PPIA also disallow certain

“prohibited” acts that involve products for use as human food that are “adulterated or misbranded

at the time of such sale, transportation, offer for sale or transportation, or receipt for

transportation” or products “required to be inspected ... unless they have been so inspected and

passed” (FMIA, 21 U.S.C. §10; PPIA, 21 U.S.C. §458).

FSIS is responsible for developing the labeling policy to determine that meat or poultry products

are wholesome, not adulterated, and properly marked, labeled, and packaged. FMIA and PPIA

both define “misbranded” foods as bearing a false or misleading label, or foods that are “offered

for sale under the name of another food,” or are “an imitation of another food, unless its label

bears, in type of uniform size and prominence,” or if “its container is so made, formed, or filled as

to be misleading, or is otherwise misrepresented” (21 U.S.C. §§ 453 and 601). An “adulterated”

food bears or contains any “poisonous or deleterious substance which may render it injurious to

health” or otherwise poses a risk to consumer health.

Perhaps more specific to food fraud, both FMIA and PPIA also define adulteration to include the

following:125

if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any

substance has been substituted, wholly or in part therefor; or if damage or inferiority has been

concealed in any manner; or if any substance has been added thereto or mixed or packed

therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear

better or of greater value than it is.

Accordingly, similar to FFDCA, a food may be deemed adulterated if a “valuable constituent” is

missing or if substances have been substituted wholly or in part or where damage or inferiority

has been concealed in any matter, or if substances have been added to “increase its bulk or

weight” (such as packing water or ice) or to raise the perceived quality of the product.

Moreover, FMIA and PPIA and federal meat and poultry inspection regulations (9 C.F.R. §§301.2

and 381.1, respectively) define “meat,” “meat food product,” “livestock,” “poultry,” and “poultry

product” and do not include species of livestock or poultry other than those specifically listed.

FSIS verifies the labeling, conducts species testing, and monitors the movement in commerce of

123

FSIS’ inspection directory, http://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/mpi-directory.

FSIS regulations are at 9 CFR 300. For meat products, labeling regulations are at 9 CFR 317; for poultry,

regulations are at 9 CFR 381. Regulations regarding weights are at 9 CFR 442. Other information on FSIS labeling

requirements is at http://www.aamp.com/regulations/fsis-labeling/.

125

FMIA (21 U.S.C. §601) and PPIA (21 U.S.C. §453).

124

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all meat and poultry food products produced under federal inspection. This includes all meat and

poultry products as well as other meat products (such as horsemeat and meat from various other

exotic animals) produced in or imported into the United States. FSIS claims that its stringent

inspection process, testing capabilities, and labeling requirements effectively prevent cases such

as those that occurred in the EU earlier in 2013, where horsemeat was labeled and sold as the

meat of another species. FSIS claims it “conducts species tests on meat and poultry products that

are produced domestically and that are imported to the United States” which are “capable of

detecting beef, sheep, swine, poultry, deer and horse.”126

Other Agency Authorities and Activities

Finally, FMIA and PPIA also broadly provide for FSIS to establish voluntary standards for meat

and poultry products (FMIA, 21 U.S.C. §607[c]; and PPIA, 21 U.S.C. §457[b]). Although not

regulatory in nature, and not intended to address potential food safety or food fraud concerns,

food quality and grading standards provide a product benchmark for certain foods or food

ingredients. Specifically, both FMIA and PPIA direct USDA to establish “definitions and

standards of identity or composition” for meat and poultry products.127 Standards of identity cover

a wide range of raw, cooked, cured, and processed meat and poultry products and ingredients for

USDA-regulated food products.

Import Authorities

Similar to that for FDA, various import security measures by USDA are conducted via various

enforcement and border inspection activities by CBP. As part of this responsibility, importers of

foreign food are responsible for verifying that the products obtained from foreign processors are

in compliance with U.S. laws.

DHS, Customs and Border Protection

CBP enforces FDA and USDA regulations at ports of entry. Import security measures, in

conjunction with existing CBP border inspections, are intended to address concerns about

possible contaminated food imports. CBP is responsible for monitoring goods and materials in

cargo shipments coming into the United States at all U.S. ports of entry, and is a regular part of

inspection procedures carried out at every port of entry nationwide.128 CBP’s border inspections

are intended to address concerns about possible contaminated food imports and are not

specifically designed to address intentional contamination of food and food ingredients. CBP

agriculture specialists prevent the entry of harmful plant and animal pests and diseases and

126

CRS inquiry (via FSIS at http://www.fsis.usda.gov/wps/portal/informational/askkaren) received December 17, 2013.

Horses are not allowed to be slaughtered and horse meat is not allowed to be processed in the same facility as other

species in the United States. FSIS notice on increased species sampling in response to horsemeat is at

http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/25-13.pdf.

127

Regulations are 9 CFR Part 319 for meat products and 9 CFR §§381.156 to 381.174 for poultry products. For

corresponding labeling information, see FSIS’ “Food Standards and Labeling Policy Book,” August 2005,

http://www.fsis.usda.gov/OPPDE/larc/Policies/Labeling_Policy_Book_082005.pdf.

128

The authority to search, inspect, and examine merchandise entering the United States is in 19 U.S.C. §1467;

regulations are at 19 C.F.R. 162.6. Other search authorities include 19 U.S.C. §§482, 1496, 1581 and 1582. These

authorities rest with the U.S. Treasury that typically delegates its authority via DHS to CBP.

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confront emerging threats in agro- and bioterrorism, as well as ensure that the required permits,

sanitary certificates (for animal products), and phytosanitary certificates (for plant products)

accompany each product shipment.129 As part of its role in enforcing plant and animal regulations,

CBP has the authority to detain, where necessary, imported or exported products pending their

clearance by agency inspectors. CBP was created in 2003 through a merger of the former U.S.

Customs Service and the agricultural inspection portion of USDA’s Animal and Plant Health

Inspection Service (APHIS).130

Imported products must meet the same standards as domestic goods, and must contain

informative and truthful labeling in English. Existing U.S. trade laws, such as general

requirements under the Tariff Act of 1930 (19 U.S.C. § 1304), require all imported articles to be

marked with the English name of the country of origin.131 Other labeling requirements also apply

under other laws that govern both FDA and USDA. For example, FDA requirements under

FFDCA require that a food label must contain specified information. However, as noted by FDA,

“The law does not specifically require that the country of origin statement be placed on the PDP

[the principal display panel, PDP, or the label panel], but requires that it be conspicuous.”132

Certain labeling requirements for meat and poultry products are also required within laws

administered by FSIS.133 Only plants in countries certified by USDA to have inspection systems

equivalent to those in this country are eligible to export products to the United States. Regulations

require that country of origin appear in English on containers of all meat and poultry products

entering the United States.134 Other USDA-administered programs also provide for additional

country-of-origin requirements for certain types of foods.135

Other Federal Food Quality or Food Safety Programs

A number of other federal agencies are involved in various food quality and food safety

programs. Although these programs are not primarily focused on food fraud, product inspections

under these programs might be leveraged to broadly address fraud concerns. In some cases

concerns related to fraud are often a component of these programs. In other cases, such as in

USDA’s program certifying products that are organically produced, enforcement against

fraudulent documents and certification is central to the program. Increased inspection and

oversight as part of a program’s product quality and marketing grades and standards may act as an

added deterrent or improve detection if fraudulent marketing or related activities are happening.

129

USDA, “Importing Food and Agricultural Products into the United States,” August 2012.

Memorandum of Agreement (MOA), DHS Agreement# BTS-03-0001 and USDA-APHIS Agreement# 03-10010382-MU, March 2003, http://www.aphis.usda.gov/plant_health/moa_dhs/downloads/article1.pdf).

131

Customs and Border Protection’s Guidance is at http://www.fda.gov/ICECI/ComplianceManuals/

CompliancePolicyGuidanceManual/ucm074567.htm. See regulations at 19 CFR 134.

132

21 CFR 101. See FDA, “Guidance for Industry: A Food Labeling Guide,” October 2009, http://www.fda.gov/Food/

GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/

ucm064872.htm.

133

FMIA (21 U.S.C. §601 et seq.) and PPIA (21 U.S.C. §451 et seq.).

134

Regulations are at 9 C.F.R. 327.14 and 9 C.F.R. 381.205.

135

Includes Country of Origin Labeling (COOL); see CRS Report RS22955, Country-of-Origin Labeling for Foods

and the WTO Trade Dispute on Meat Labeling; and Perishable Agricultural Commodities Act (PACA) of 1930 and the

Produce Agency Act of 1937 (7 U.S.C. §499a et seq., and §1622, respectively); see CRS Report R42771, Fruits,

Vegetables, and Other Specialty Crops: Selected Federal Programs.

130

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USDA, Agricultural Marketing Service

Product Quality, Grading, and Standards

AMS is primarily responsible for product quality and marketing grades and standards for a range

of foods, including dairy products, fruits and vegetables, livestock, meat, poultry, seafood, and

shell eggs. However, AMS administers the egg surveillance program that inspects egg facilities

quarterly to insure that egg handlers maintain required records and properly dispose of restricted

eggs.136 AMS also certifies quality programs and conducts quality grading services, generally user

fee-funded. These programs are generally voluntary in nature, and in most cases do not directly

address adulteration of food and food ingredients.

USDA programs establishing quality grade standards to encourage uniformity and consistency in

commercial practices are provided for under the Agricultural Marketing Act of 1946 (7 U.S.C.

§1621).137 AMS develops quality grade standards for commodities as needed by the agriculture

and food industry for a range of products, including cotton; dairy products; fresh and processed

fruits and vegetables (and fruits and vegetables for processing); nuts and other specialty crops;

livestock (including wool and mohair); poultry and eggs (including rabbits); and tobacco.138

Under federal-state agreements, AMS-licensed state employees work where needed: in fields

during harvest; at land, sea, and air ports of entry; and at packing houses, processing plants,

warehouses, and federal and federal-state terminal markets. Grading is paid for by user fees and is

voluntary unless the commodity is regulated for quality under a marketing order or agreement,

subject to export requirements, or purchased by USDA or another federal agency for distribution

(e.g., through the school lunch program or the military). Shipments of any imported commodity

whose domestic production is under a marketing order or agreement must receive AMS grading

to assure that the produce is comparable to the U.S. grade, size, quality, and maturity

requirements.

Certified Organically Produced

AMS also oversees and enforces the USDA organic certification program, the National Organic

Program (NOP). NOP is authorized under the Organic Foods Production Act of 1990, and the

program’s labeling and certification requirements are enforceable, and address concerns about

fraud through product mislabeling.139

NOP regulations require that agricultural products labeled as “organic” originate from farms or

handling operations certified by a state or private entity that has been accredited by USDA.

Administered by AMS, NOP is a regulatory program that became operational in 2002,

establishing a voluntary production and handling certification program. The program specifies the

methods, practices, and materials that may be used and how certified organic production is to be

grown, raised, and processed.140 A central part of the NOP’s stated mission is to “ensure the

136

Egg Products Inspection Act, as amended (21 U.S.C. §§1031-1056), 7 CFR Part 57.

7 U.S.C. §§1621 et seq., 7 CFR Part 75.

138

USDA, “USDA Quality Standards,” http://www.ams.usda.gov/standards/.

139

7 U.S.C. §§6501-6522, 7 CFR Part 205. OFPA was enacted as part of the 1990 farm bill (P.L. 101-624).

140

NOP regulations prohibit the use of genetic engineering, irradiation, and sewage sludge in certified organic

production and handling.

137

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integrity” of USDA-certified organic products according to national standards for organically

produced agricultural products that “assure consumers that products with the USDA organic seal

meet consistent, uniform standards.”141 Since there are no tests that prove whether a food or

ingredient is organically produced, certification relies on having the proper paperwork showing

that processes were followed. Using fraudulent documents or certification to market, label, or sell

non-organic (conventionally produced) food and food ingredients as USDA-certified “organic” is

a violation of U.S. law and federal National Organic Program (NOP) regulations, punishable by

fines of up to $11,000 for each violation.142

NOAA, National Marine Fisheries Service

NOAA’s National Marine Fisheries Service (NMFS) administers a number of seafood and

fisheries safety and sanitation programs. NMFS’s voluntary seafood and fisheries safety

inspection program focuses on marketing and product quality under the authority of the

Agricultural Marketing Act of 1946 (7 U.S.C. §1621 et seq.).143 The program offers additional

levels and types of inspection that exceed FDA requirements, which program participants also

must meet. Examples include onsite NOAA inspections during production hours, certification that

plants or vessels meet specified sanitation requirements, quality inspections of individual product

lots, and/or laboratory testing of products, among other services. NMFS works with FDA, which

helps provide training and other technical assistance to NMFS. As part of its guidance, NOAA

identifies common seafood fraud consisting of the addition of water or ice to add weight to the

product; use of masking agents (such as carbon monoxide in tuna) that may give the fish added

color or make it seem much fresher than it actually is; and also seafood substitution or labeling

and selling a less expensive fish product as a more expensive product.144

Under the program, NMFS inspects a reported 20% of the seafood consumed in the United

States.145 Industry generally contracts with NMFS to provide the service, and NMFS personnel

may inspect fishing vessels and processing plants to ensure that sanitary practices are in keeping

with FDA standards. These services are provided on a fee-for-service basis and entitle

participants to use various official grading and labeling marks, which are viewed as making their

products more attractive to buyers. Exporters are often users of these services, in part because of

foreign buyer requirements. NMFS may also periodically evaluate products at processing

facilities for general condition, wholesomeness, and proper grading and labeling; and they may

sample products for chemical and microbiological contamination, decomposition, and species

identification.146

141

For information, see USDA’s website (http://www.ams.usda.gov/AMSv1.0/nop). See also NOP’s “Fact Sheet,”

NOP’s “2010-2012 Strategic Plan,” and “National Organic Program,” http://www.ams.usda.gov/AMSv1.0/organicinfo.

142

NOP’s website lists prior and ongoing cases of fraudulent organic certificates at http://www.ams.usda.gov/nop.

143

NOAA Seafood Inspection Program, http://www.seafood.nmfs.noaa.gov/Program_Services.html. See also CRS

Report RS22797, Seafood Safety: Background and Issues. For more direct assistance, contact (name redacted), Analyst

in Natural Resources Policy ([redacted]@crs.loc.gov, 7-....).

144

See, for example, NOAA, “Identifying Seafood Fraud: A Common Practice with Serious Consequences,”

http://www.fishwatch.gov/buying_seafood/identifying_seafood_fraud.htm.

145

NOAA, “Inspecting Seafood—A Highly Trained Nose Knows,” Fishwatch.gov, http://www.fishwatch.gov/features/

steve_wilson_10_15_12.htm.

146

FDA, “2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices,” August 2012,

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm315486.htm.

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In addition, NOAA works with FDA and other federal agencies, as well as various state agencies,

under the National Shellfish Sanitation Program (NSSP). NSSP is a federal/state cooperative

program recognized by FDA and the Interstate Shellfish Sanitation Conference (ISSC) to promote

and improve the sanitation of shellfish—oysters, clams, mussels, and scallops—moving in

interstate commerce through federal/state cooperation and to promote uniformity of state shellfish

programs.147 Participants include agencies from states, FDA, EPA, NOAA, and the shellfish

industry, and also foreign governments. Such cooperative efforts may act as a further deterrent to

fraudulent activities, or improve detection if fraud is occurring.

Congressional Actions Involving Food Fraud

Congress has introduced a number of bills intended to address concerns about food fraud, mostly

with respect to concerns about a particular food or food ingredient, but has not introduced

legislation that would specifically address fraud in a comprehensive manner.

Most previous legislation in the past few years has tried to address fish and seafood fraud mostly

through improved inter-agency cooperation and coordination. These include H.R. 1012/S. 520

(Markey/Begich) in the 113th Congress, S. 50 (Inouye) in the 112th Congress, and S. 3928

(Inouye) in the 111th Congress. Increased inspections of foreign seafood facilities were proposed

in S. 2934 (Vitter) in the 111th Congress. Other previously introduced legislation would address

fraudulent maple syrup (for example, H.R. 3363 in the 112th Congress).

Among other legislation introduced in the 113th Congress is H.R. 2400 (Capps), which seeks to

improve recordkeeping and authorize investigations and enforcement actions for violations of the

organic products standards. Previous congressional efforts have also highlighted concerns about

fraudulently labeled “organic” products that might undermine the USDA-certified organic food

industry.148

In addition, both the House-passed and Senate-passed versions of the 2013 farm bill (H.R.

2642/S. 954) include a provision to require USDA to submit a report to FDA that describes an

appropriate federal standard for the identity of honey. This provision relates to previous

congressional effort to push FDA to create “pure honey” standards that would allow federal

border agents to better combat adulteration, misbranding, and fraudulent mislabeling of honey.149

A previous version of the House farm bill had also contained a provision that would establish

tighter import controls on olive oil imports to enforce quality standards under the Agricultural

Adjustment Act (7 U.S.C. §608e-1[a]).150 This provision was removed by amendment during

floor debate (H.Amdt. 213).

147

Information is at FDA, http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2006754.htm. As

part of a 1984 Memorandum of Understanding, ISSC was recognized as the primary voluntary national organization of

state shellfish regulatory officials, providing guidance and counsel on matters for the sanitary control of shellfish.

148

See, for example, letter from Senator Charles E. Schumer to USDA Secretary Tom Vilsack, September 20, 2010,

available at http://www.schumer.senate.gov/Newsroom/record_print.cfm?id=327768.

149

See, for example, Senator Schumer’s press release on June 11, 2010, regarding a letter sent to FDA Commissioner

Margaret Hamburg. See also J. Pecquet, “Schumer: ‘Honey laundering’ a sticky problem that needs FDA intervention,”

The Hill, June 12, 2010.

150

H.R. 1947, §10010. See, for example, N. Flagg, “New Farm Bill Includes Olive Oil Controls,” May 20, 2013.

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Author Contact Information

(name redacted)

Specialist in Agricultural Policy

[redacted]@crs.loc.gov, 7-....

Congressional Research Service

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