U.S. Food and Agricultural Imports: Safeguards and Selected Issues

U.S. Food and Agricultural Imports: Safeguards July 1, 2020
and Selected Issues
Renée Johnson
High-profile foodborne outbreaks and incidents involving imported foods have generated
Specialist in Agricultural
growing concerns about whether current federal programs sufficiently ensure the safety of these
Policy
imports. Safety concerns have been associated with imported products from China, Mexico, and

nations in Central and South America, Southeast Asia, Europe, and elsewhere. Imports of fish
and seafood, fruits and vegetables, and pet foods are among those that have been associated with

foodborne outbreaks and incidents. It is unclear whether imported foods pose a greater safety risk
than domestically produced foods. Available data on foodborne illness outbreak investigations do not readily identify
whether the food is domestic or foreign sourced.
A steady increase in the volume of food imports—a result of globalization and consumer desire for a wider variety of foods
year-round—complicates efforts to secure the safety of imported foods and strains already-challenged U.S. food inspection
and oversight services. Overall, imported foods account for about one-fifth of all foods consumed in the United States, but an
even larger share for some foods, such as fish and seafood, and fruit and vegetable products.
Numerous federal, state, and local agencies share responsibilities
Number of Imported Food Shipments to the
for regulating the safety of the U.S. food supply. State and local
United States by Exporting Country/Region
authorities are thought to account for as much as 90% of all the
food inspections in the United States through their routine
sampling, inspection, and food-testing work.
Federal responsibility for food safety rests primarily with the
Food and Drug Administration (FDA) and the U.S. Department
of Agriculture (USDA). FDA, an agency of the Department of
Health and Human Services, is responsible for ensuring the
safety of all domestic and imported food products (except for
most meats and poultry). FDA also has oversight of all seafood,
fish, and shellfish products. More than 210,000 foreign food
facilities are registered with FDA and are potentially subject to
inspection. USDA’s Food Safety and Inspection Service (FSIS)
regulates most meat (including catfish) and poultry and some
egg products. Roughly 1,300 eligible foreign establishments fall

under FSIS jurisdiction.
Source: FDA, FDA Strategy for the Safety of Imported Food, February 2019.
In FY2019, FDA inspected more than 1,700 foreign facilities and examined 17.7 million import lines (referring to separate
product lines on an entry document) of FDA-regulated foods. For meat and poultry imports, FSIS audits the meat inspection
systems of foreign countries that are approved to export meat and poultry products to the United States. Upon entry into the
United States, FSIS reinspects the imported products.
Changes enacted in the FDA Food Safety Modernization Act (FSMA, P.L. 111-353) gave FDA new tools and authorities to
ensure imported food meets the same safety standards as food produced in the United States. However, FDA continues to
examine about 1% of the total number of food import lines each year—rates similar to that prior to FSMA. FSMA mandates
requiring an increase in the number of facility inspections and an increase in the number of FDA inspectors have also not
kept pace with targets set by Congress. As part of its ongoing oversight, Congress may wish to continue monitoring FDA’s
progress in implementing FSMA and examine the agency’s ability to ensure the safety of imported foods. Some in Congress
also continue to question the safety of imported foods under USDA’s jurisdiction and have scrutinized the agency’s process
for determining the eligibility of foreign establishments to export meat and poultry products to the United States, particularly
for products originating from certain countries. Congress may consider whether tighter requirements are necessary regarding
such imports.
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Contents
Trends in U.S. Food Product Imports .............................................................................................. 1
Value of Trade ........................................................................................................................... 1
Volume of Trade ........................................................................................................................ 4
Food Imports as a Share of U.S. Consumption ......................................................................... 6
Federal Food Safety Agencies and Authorities................................................................................ 8
Food and Drug Administration ................................................................................................ 10
FSMA Provisions Addressing Imports ............................................................................... 11
FDA Foreign Facility Inspections ..................................................................................... 15
FDA Foreign Systems Recognition Assessment ............................................................... 18
Technical Assistance for Foreign Food Suppliers ............................................................. 19
FDA Inspection of Imported Foods .................................................................................. 20
FDA’s Authority to Refuse Import Shipments ................................................................. 22
FDA’s Import Data Reporting Requirements ................................................................... 23
Measures of Effectiveness of FSMA Mandates ................................................................ 24
USDA, Food Safety and Inspection Service ........................................................................... 25
FSIS Foreign Facility Inspection ...................................................................................... 26
FSIS Inspection System Equivalency Determination ....................................................... 26
FSIS Reinspection of Imported Food ............................................................................... 27
FSIS’s Authority to Refuse Import Shipments ................................................................. 28
Food Safety Concerns Involving Imports ...................................................................................... 29
Foodborne Outbreaks Involving Imported Foods ................................................................... 32
FDA Import Violations and Shipment Refusals ...................................................................... 33
USDA Import Violations and Shipment Refusals ................................................................... 37
Congressional Considerations ....................................................................................................... 38

Figures
Figure 1. Value of U.S. Agricultural and Fish/Seafood Trade, 1990-2019 ...................................... 2
Figure 2. Value of Trade, Selected Fish and Shellfish Products ...................................................... 4
Figure 3. Value of Trade, Fresh and Processed Fruits and Vegetables ............................................ 4
Figure 4. Number of Imported Food Shipments by Exporting Country/Region ............................. 5
Figure 5. Volume of U.S. Food Imports, by Food Group ................................................................ 6
Figure 6. Volume of Trade, Selected Fish and Shellfish Products ................................................... 6
Figure 7. Actual versus FSMA-Mandated Inspections of Foreign Food Facilities ....................... 16
Figure 8. Foreign Preventive Controls Inspections (FY2017-FY2019) ........................................ 25
Figure 9. Foreign Supplier Verification Program Inspections (FY2017-FY2019) ........................ 25
Figure 10. Number of Outbreaks Caused by Imported Foods and Total Number of
Outbreaks with a Food Reported, United States, 1996-2014 ..................................................... 32
Figure 11. FDA Import Refusals, by Violation Charges, 2005-2013 ............................................ 34
Figure 12. FDA Imported Food Refusals, by Percentage Share .................................................... 36
Figure 13. Number of Adulteration Violations, 2005-2013 ........................................................... 36

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Tables
Table 1. U.S. Imports of Agriculture, Fish and Forest Products, 1990-2019 .................................. 3
Table 2. Leading Food Exporting Countries to the United States, 2018 ......................................... 5
Table 3. Imports as a Share of Consumption Based on Volume of Foods Consumed ..................... 7
Table 4. Imports as a Share of Consumption Based on Product Value ............................................ 8
Table 5. FDA Food Safety Inspections of Imported Foods, FY2010-FY2018 ............................... 11
Table 6. Imported Meat, Poultry, Egg Product Reinspection and Refusal, 2005-2019 ................. 28
Table 7. Number of Violations, by Selected Charge Code for Selected Years .............................. 35

Appendixes
Appendix. Role of Other Federal Agencies ................................................................................... 42

Contacts
Author Information ........................................................................................................................ 49

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ver the past few decades, a number of high-profile foodborne illness incidents and
outbreaks involving imported foods have generated growing concerns about whether
O current federal programs sufficiently ensure the safety of these imports. Foodborne illness
incidents and outbreaks involving imported foods have been associated with products from
China, Mexico, nations in Central and South America, Southeast Asia, Europe, and elsewhere.
Compounding concerns about the safety of imported foods is the fact that the volume of imports
continues to steadily increase, in part given increased globalization but also rising consumer
demand for a wider variety of foods year-round. Food imports now account for a growing share
of all foods consumed in the United States. The U.S. Department of Agriculture (USDA) reports
that food imports account for about one-fifth of all U.S. food consumed (regardless of whether
measured by volume or product value of trade). Imports account for an even greater share of total
consumption for some foods, including fish and seafood, and fruit and vegetable products.
Numerous agencies share responsibility for ensuring the safety of the U.S. food imports. Federal
responsibility for food safety—covering both imported and domestically produced foods—rests
primarily with the Food and Drug Administration (FDA) at the Department of Health and Human
Services (HHS) and the Food Safety and Inspection Service (FSIS) at USDA. FDA is responsible
for regulating the safety and labeling of most foods and beverages (excluding alcohol) and the
manufacture and distribution of shell eggs, most seafood, drugs, and animal feeds. FSIS is
responsible for regulating the safety and labeling of meat, poultry, egg products, and catfish.
Trends in U.S. Food Product Imports
Value of Trade
In 2018-2019, the United States was a net importer of agricultural and fish products, reversing a
period of a U.S. trade surplus over the past decade (Figure 1). While U.S. agricultural exports
have increased, so have imports. From FY2015 to FY2019, U.S. agricultural exports averaged
about $142 billion per year, while U.S. imports averaged slightly higher at $143 billion per year.
Trade data presented here cover agricultural products as defined by USDA for the purposes of
calculating U.S. agricultural exports and imports and the agricultural trade balance. This
definition includes raw and bulk agricultural commodities (e.g., grains and oilseeds), meat and
dairy products, fruits and vegetables, nursery products, wine, and cotton fiber products (see text
box
). USDA’s definition typically does not include certain other agriculture related products,
which cover fish and seafood, distilled spirits and other beverages, manufactured tobacco
products, and forestry and bioenergy products. Fish and seafood are often not included in official
U.S. agricultural statistics. This is consistent with the World Trade Organization’s (WTO’s)
Agreement on Agriculture, which excludes fish and seafood products from its list of products
covered by the agreement.1 As the United States remains a net importer of fish and seafood
products, the inclusion of fish and seafood data as part of the overall trade picture results in a net
trade deficit (Figure 1). From FY2015 to FY2019, U.S. fish and seafood exports averaged about
$6 billion per year, while U.S. imports averaged about $11 billion per year.
Table 1 provides additional detail on a range of agricultural products and other agriculture
related products
, including fish and seafood, and forestry products. It excludes distilled spirits
and agriculture-derived bioenergy products.

1 WTO, Agreement on Agriculture, Annex 1, https://www.wto.org/english/docs_e/legal_e/14-ag.doc. See also USDA,
Profiles of Tariffs in Global Agricultural Markets, AER-796, Appendix, January 2001, https://www.ers.usda.gov/
publications/pub-details/?pubid=41257.
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U.S. Food and Agricultural Imports: Safeguards and Selected Issues

Figure 1. Value of U.S. Agricultural and Fish/Seafood Trade, 1990-2019

Source: CRS from USDA’s Global Agricultural Trade System data (FATUS product group). As defined by
USDA, “Agricultural” trade including selected (non-ag) fish and seafood products (excluding fertilizer and
agricultural chemicals, farm machinery, and tobacco products). AIt also excludes distil ed spirits.
Notes: Agricultural products exclude re-exports and reflect USDA-revised data for domestic exports and
imports for consumption, customs value basis.
USDA’s Definition of Agricultural Products in U.S. Trade
USDA’s definition of agricultural products (often referred to as “food and fiber" products)—for the purposes of
calculating U.S. agricultural exports and imports and the agricultural trade balance—covers a broad range of goods
from unprocessed bulk commodities, intermediate products, and consumer-oriented products. This includes
grains for human consumption and animal feed; raw cotton; meat and poultry products; milk and dairy foods; fresh
and processed specialty crops (fruits, vegetables, tree nuts, nursery products, honey, and wine); highly processed
high-value foods and beverages (such as sausages, bakery goods, ice cream, beer, and condiments); tropical
products (such as sugar, cocoa, and coffee); fats and oils; hides and skins; wool and mohair; and unmanufactured
tobacco. Generally, most of the products in Chapters 01-23 of the U.S. Harmonized Tariff Schedule (HTS) include
agricultural products. Exceptions include fishery products (Chapters 03 and 16) and distil ed spirits (Chapter 22).
Other products are also considered agricultural products. These include essential oils (Chapter 33), raw rubber
(Chapter 40), raw animal hides and skins (Chapter 41), and wool and cotton (Chapters 51-52). These data exclude
manufactured tobacco products such as cigarettes and cigars (Chapter 24).
Some products derived from plants or animals are considered to be nonagricultural because of their manufactured
nature, such as cotton thread and yarn, fabrics and textiles, clothing, leather and leather goods, cigarettes and
cigars, and distil ed spirits. Others are considered to be agricultural related products, such as fishery and seafood
products (given their food value) and solid wood products (given that USDA promotes U.S. exports of these
products). USDA’s definition of agricultural related products included fish and shellfish products, distil ed spirits,
forest products, and ethanol and biodiesel blends.
Source: USDA, “GATS Agricultural Products Definition,” https://apps.fas.usda.gov/gats/AgriculturalProducts.aspx.
See also, for example, USDA, Profiles of Tariffs in Global Agricultural Markets, AER-796, Appendix, January 2001,
https://www.ers.usda.gov/publications/pub-details/?pubid=41257. The exclusion of fish and seafood products is
consistent with coverage under the WTO’s Agreement on Agriculture (Annex 1).
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Table 1. U.S. Imports of Agriculture, Fish and Forest Products, 1990-2019
1990
2000
2010
2015
2018
2019
2019

Product
($billions)
Ag, Fish & Forest Prods
33.24
64.32 107.77 148.49 171.67 170.39 100.0%
Consumer-Oriented
13.95
25.97
51.93
75.90
90.29
93.85
55.1%
Fruit, Vegetable, Tree Nut Products
5.46
9.05
20.58
29.75
36.19
37.23
21.8%
Cheese and Dairy Products
0.87
1.55
2.17
3.02
2.95
3.16
1.9%
Red Meats
2.93
3.77
4.78
9.44
8.67
9.10
5.3%
Wine and Beer
1.83
4.42
7.80
10.09
11.78
12.12
7.1%
Snack Foods
0.88
2.47
5.80
8.03
9.88
10.49
6.2%
Other Consumer-Oriented Products
1.98
4.72
10.80
15.57
20.81
21.75
12.8%
Intermediate Total
4.08
7.00
16.71
23.12
24.94
24.30
14.3%
Live Animals, Hides and Skins
1.32
2.03
2.39
3.38
2.63
2.87
1.7%
Vegetable and Tropical Oils
0.67
1.29
4.11
5.47
6.49
5.81
3.4%
Sugars, Sweeteners, Cocoa Paste
0.63
0.62
2.69
2.38
2.26
2.37
1.4%
Essential Oils
0.22
0.33
2.46
3.45
4.30
4.10
2.4%
Other Intermediate Products
1.25
2.72
5.06
8.44
9.26
9.15
5.4%
Bulk Total
4.89
6.00
13.22
14.62
13.49
12.89
7.6%
Coffee, Tea, Cocoa
2.28
3.01
5.89
7.27
6.41
6.25
3.7%
Other Bulk Products
2.60
2.99
7.33
7.35
7.08
6.64
3.9%
Seafood and Fish Products
5.2
9.9
14.6
18.6
22.3
21.9
12.8%
Tuna and Salmon
0.8
1.0
2.0
1.9
2.6
2.6
1.5%
Shrimp
1.7
3.8
4.3
5.4
6.2
6.0
3.5%
Other Seafood and Fish Products
2.7
5.2
8.3
11.2
13.5
13.3
7.8%
Forest Products
5.15
15.45
11.35
16.29
20.60
17.48
10.3%
Source: CRS from USDA’s Global Agricultural Trade System data (BICO-HS10 product group). As defined by
USDA, “Agriculture, Fish, and Forest Products” includes bulk and intermediate agricultural products, consumer-
oriented products, fish and seafood, and forest products. It excludes and other related agricultural products such
as distil ed spirits and biodiesel blends.
Notes: May not add due to rounding. Data are not adjusted to account for inflation.
USDA aggregate agricultural trade surplus data often mask trade imbalances for certain traded
goods, including fish and seafood (Figure 2) and fresh and processed fruits and vegetables
(Figure 3). Currently, by value, the United States imports more fish and seafood and more fruit
and vegetables than it exports, resulting in a deficit in trade for these broad product categories.2

2 The deficit for fruits and vegetables cannot be solely explained by imports of bananas and other tropical fruits, which
are generally not grown in the United States. For more information, see CRS Report RL34468, The U.S. Trade
Situation for Fruit and Vegetable Products
.
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U.S. Food and Agricultural Imports: Safeguards and Selected Issues

Figure 2. Value of Trade, Selected Fish
Figure 3. Value of Trade, Fresh and
and Shellfish Products
Processed Fruits and Vegetables


Source: CRS from USDA Global Agricultural
Source: CRS from U.S. International Trade
Trade System, calendar year data,
Commission’s Trade DataWeb, calendar year data,
https://apps.fas.usda.gov/gats/default.aspx.
https://dataweb.usitc.gov/. Excludes fresh nuts
(HTS 801 and 802).
Across all product categories—including fish and shellfish and other agriculture related
products—more than one-third of the value of U.S. agricultural imports in 2018 were supplied by
Canada and Mexico, with another 17% supplied by the European Union. China accounted for
about 5% of the value of U.S. agricultural imports, while Chile, India, and Indonesia supply
roughly 3% each. Table 2 lists other leading U.S. food importing countries.
Figure 4 shows the number of imported food shipments by exporting country or region.3 These
data further indicate that the number of shipments to the United States from all major suppliers
has risen sharply over the past several years.
Not all agricultural imports enter the human food supply; some products are used as ingredients
in pet food and animal feed, in manufactured goods (e.g., rubber), and in the nursery plant trade.
Volume of Trade
By volume, food imports have steadily increased in all food product categories since the 1990s
(Figure 5). From 1999 to 2017, volume imports of selected foods rose from 32 million metric
tons (MMT) to nearly 60 MMT.4 Increases were greatest for imports of fruits and vegetables,
prepared grain and bakery goods, and other ready-to-eat products. By value, these types of
consumer-oriented products account for more than half of all U.S. food imports (Table 1).
Other more detailed data also show increases in volume imports of fish and shellfish products,
which have increased since the 1990s, reaching over 2.8 MMT in 2018.5 Fish products accounted
for about 60% of this total import volume in 2018, with shellfish accounting for the remainder
(Figure 6).

3 FDA, “FDA Strategy for the Safety of Imported Food,” February 2019. Data are reported by FDA from data in its
Operational and Administrative System for Import Support (OASIS), 2018.
4 USDA’s U.S. Food Imports data (https://www.ers.usda.gov/data-products/us-food-imports/). Data through 2017 are
the most recent available.
5 Converted from reported pounds. USDA, “Aquaculture Data,” http://www.ers.usda.gov/data-products/aquaculture-
data.aspx. The volume of total U.S. aquaculture exports totaled about 0.2 MMT in 2018 (excluding trade in live trout
and ornamental fish).
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U.S. Food and Agricultural Imports: Safeguards and Selected Issues

Table 2. Leading Food Exporting Countries to the United States, 2018
Exporting
Value
Share
Country
($billion) (%Value)
Major Food Product Imports (based on value)
Mexico
27.2
18.0%
Fresh/prepared fruits/vegetables, spirits/beverages, sugar/confectionary
EU-28
26.0
17.2%
Wine/spirits, baked goods, fats/oils, dairy products, prepared fruits/vegetables
Canada
25.6
16.9%
Meat products, cereals/baked goods, seafood, fats/oils
China
7.5
5.0%
Fresh/prepared fish/seafood, prepared fruits/vegetables
Chile
5.2
3.4%
Fruit, seafood, wine/beverages
India
4.8
3.1%
Fresh/prepared fish/seafood, gums/resins, tea/spices, oilseeds/legumes
Indonesia
4.2
2.8%
Fresh/prepared fish/seafood, fats/oils, coffee/spices, cacao products
Vietnam
3.8
2.5%
Fresh/prepared fruits, fresh/prepared fish/seafood, coffee
Brazil
3.8
2.5%
Coffee, beverages, processed fruits vegetables
Thailand
3.6
2.4%
Fresh/prepared fish/seafood, cereals animal feed, prepared fruits
Australia
3.2
2.1%
Meat products, wine, grains
Colombia
2.7
1.8%
Coffee, nursery plants, fruits
New Zealand
2.5
1.7%
Meat, beverages, dairy products, fruit, fresh fish/seafood
Peru
2.5
1.7%
Fresh/prepared fruits/vegetables, coffee/tea/spices, fresh fish/seafood

All Other
28.8
19.0%
Source: CRS, from trade data posted at the U.S. International Trade Commission’s Interactive Tariff and Trade
DataWeb database, covering HTS codes in chapters 1-24 (includes fish, seafood, distil ed spirits, and tobacco
products). Shares based on a subtotal of $151.5 bil ion.
Notes: EU-28 includes the current 28 member states of the European Union, including the United Kingdom.
Figure 4. Number of Imported Food Shipments by Exporting Country/Region

Source: FDA, FDA Strategy for the Safety of Imported Food, February 2019. Data are reported by FDA from data
in its FDA’s Operational and Administrative System for Import Support (OASIS), 2018.
Notes: All products offered for entry into the United State must be declared to the U.S. Customs and Border
Protection, including commercial shipments (or imported goods brought into U.S. commerce for sale or
distribution) and items for personal use.
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U.S. Food and Agricultural Imports: Safeguards and Selected Issues

Figure 5. Volume of U.S. Food Imports,
Figure 6. Volume of Trade, Selected Fish
by Food Group
and Shellfish Products


Source: CRS from USDA U.S. Food Imports data
Source: CRS from USDA Global Agricultural
(fiscal year, most recent available data),
Trade System, calendar year data,
https://www.ers.usda.gov/data-products/us-food-
https://apps.fas.usda.gov/gats/default.aspx.
imports/. Excludes some product groups, including
live meat animals and beverages.
Food Imports as a Share of U.S. Consumption
Available data reported by USDA indicate that imports account for a growing portion of
American diets and the U.S. food supply. Table 3 and Table 4 show two sets of USDA estimates
of import shares based, respectively, on the volume of food consumed and the value of food
products. Regardless of the measure, imported foods account for an average of about one-fifth of
all foods consumed or marketed in the United States each year. There are notable differences,
however, between these two USDA datasets and estimates for individual food products.
Table 3 shows import shares based on the volume of foods consumed from a discontinued USDA
dataset that last reported estimates through 2013.6 For 2016-2017, estimates shown are calculated
using other limited available USDA data.7 Based on the volume of food consumed, available
USDA estimates of import shares are calculated based on the commercial disappearance of a
food product, as measured by total production adjusted for changes in beginning and ending
stocks and changes in trade (exports and imports). Estimates of import share vary widely
depending on the type of food. Import shares are greater for fish and seafood,8 tropical products9
(imports account for more than 90% of food consumed by volume), spices (nearly 90%), tree nuts
(more than 30%), fruit juices (more than 50%), and fresh fruits and vegetables (more than 20%).
Import shares are lower for dairy (about 3% of all dairy products consumed) and meat (between
5% and 10%, depending on whether beef or poultry products). Compared to the 1990s, imports as
a share of U.S. food consumption have risen sharply for most food and agricultural products.

6 For more information, for example, see A. Jerardo, The Import Share of U.S.-Consumed Food Continues to Rise,
FAU-66-01, Economic Research Service (ERS), July 2002.
7 Calculated by CRS using ERS’s Food Availability (Per Capita) Data System, available at http://www.ers.usda.gov/
topics/international-markets-trade/us-agricultural-trade/import-share-of-consumption.aspx.
8 Other estimates by the National Oceanic and Atmospheric Administration (NOAA) report that imported seafood as a
share of consumption was 94% in 2018. See NOAA, Fisheries of the United States 2018, Current Fishery Statistics No.
2018, p. 116, https://www.fisheries.noaa.gov/resource/document/fisheries-united-states-2018-report. NOAA says its
existing model overestimates this percentage and that the agency is investigating improvements.
9 Includes coffee, cocoa, and tea—products not widely grown in the United States.
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Table 3. Imports as a Share of Consumption Based on Volume of Foods Consumed
1990
2000
2005
2012
2013
2016
2017

Product Category
(percentage based on estimated commercial disappearance)
Total Consumed Food
12.1
14.2
17.1
18.3
19.1
N/A
N/A
Beef
9.8
11.1
13.0
8.7
8.9
11.4
11.0
Pork
5.6
5.2
5.4
4.4
4.7
5.1
5.2
Poultry and eggs
0.0
0.1
0.1
0.4
0.4
0.4
0.4
Dairy products
1.9
2.7
4.2
2.2
2.1
3.2
2.7
Fish and shellfish
56.3
68.3
84.3
87.8
96.2
96.3
91.7
Grains
10.1
14.4
13.2
12.5
15.5
NA
NA
Rice, mil ed
8.6
13.7
21.1
26.4
27.5
NA
NA
Sugar, cane and beet
32.1
16.6
21.5
30.6
28.8
21.8
20.2
Spices
77.7
84.7
87.7
88.8
86.3
NA
NA
Tropical products
99.8
99.2
102.0
97.5
96.4
NA
NA
All fresh fruits
34.9
20.5
21.5
24.5
24.1
NA
NA
All fruit juices
37.9
31.1
40.6
48.1
55.6
NA
NA
All tree nuts
31.5
39.9
54.5
39.2
44.7
31.4
34.0
All fresh vegetables
8.6
11.2
14.9
20.8
22.0
NA
NA
Source: 1990-2013 (USDA/ERS, discontinued dataset); 2016-2017 calculated by CRS using available limited data
from ERS as part of its Food Availability Data System (http://www.ers.usda.gov/topics/international-markets-
trade/us-agricultural-trade/import-share-of-consumption.aspx). Commercial disappearance is estimated based on
production and changes in stocks and trade (imports and exports). Tropical products include coffee, cocoa, tea,
and spices. More recent data are not available.
Table 4 shows USDA estimates based on the value of food products, both imported and
domestically produced.10 Based on product value, available USDA estimates are measured from
the combined value of both imported and domestically produced foods. As such, these estimates
may be influenced by differences in relative prices between imported and domestic products.
Price differences may skew import shares lower in the case of lower-cost raw commodity
imports; alternatively, price differences may result in higher import shares in the case of higher
priced value-added processed foods. Among processed (manufactured) food products, grain and
oilseed milling products and sugar and confections are among the highest share imported
products (based on value). Sweeteners (sugarcane, sugar beets, honey), vegetables and melons,
and fruits and tree nuts are the highest share products of raw (non-manufactured) goods.
Compared to 2008, these data show mostly slight increases in import shares over time.
Compared to import shares based on the volume of foods consumed, estimates shown in Table 4
often differ significantly from estimates shown in Table 3. For example, based on the volume of
food consumed, import shares for dairy products are estimated at 3%, and import shares for meat
products are estimated to range from 5% to 10%. In contrast, based on value, import shares are
much higher for these products, estimated at 9% to 11% for dairy products and 18% to 22% for
meat products. Estimates of import shares based on value are not available for fish and seafood
products. These discrepancies, along with the likelihood that differences in relative prices might

10 Available at https://www.ers.usda.gov/topics/international-markets-us-trade/us-agricultural-trade/data/.
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influence differences in these estimates, raise questions about the potential usefulness of USDA’s
estimates based on import value for tracking imports as a share of the U.S. market.
Table 4. Imports as a Share of Consumption Based on Product Value
2008
2010
2012
2013
2014
2015
2016
Product Category
(percentage based on value)
Total Food and Beverages
12.0
11.8
13.0
13.1
13.5
14.6
14.8
Grain/oilseed mil ing products
31.7
31.3
43.3
48.9
54.6
47.3
45.2
Sugar and confections
31.6
33.7
37.3
36.2
37.1
36.0
36.2
Preserved fruit and vegetables
24.4
22.5
25.5
24.9
26.1
25.7
26.5
Dairy products
9.7
6.8
9.1
9.9
11.1
10.1
9.0
Meat products
14.4
13.8
18.8
18.4
21.0
21.8
18.0
Bakery products
8.2
8.5
10.4
10.4
10.4
10.7
11.4
Beverages
12.7
13.6
22.2
19.1
18.1
17.3
16.0
Food grains
28.3
18.4
14.6
29.0
22.1
24.1
21.9
Feed grains
2.0
1.0
1.6
2.3
1.6
1.9
1.7
Oilseeds
7.2
3.4
4.2
5.3
9.8
6.4
4.2
Fresh vegetables and melons
26.0
29.1
31.2
31.7
32.8
31.7
36.1
Fresh fruits and tree nuts
35.9
37.2
34.8
36.3
39.6
44.5
45.3
Sweeteners
38.4
45.0
44.1
38.9
45.8
46.9
44.5
Livestock
3.6
2.9
2.6
2.5
2.9
2.9
2.8
Source: USDA/ERS; U.S. Department of Commerce (available at https://www.ers.usda.gov/topics/international-
markets-us-trade/us-agricultural-trade/data/). More recent data are not available.
Federal Food Safety Agencies and Authorities
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the
U.S. food supply, including imported foods.11 Federal responsibility for food safety rests
primarily with FDA and USDA. FDA is responsible for ensuring the safety of all domestic and
imported food products (except for most meats and poultry). FSIS regulates most meat and
poultry and egg products and catfish. For imported foods, FDA and FSIS rely on different
regulatory systems, including how each agency determines whether foreign food suppliers have
safety systems and standards comparable to those in the United States (see text box).
The Appendix describes the role of other federal agencies in ensuring the safety of imported food
and agricultural products. For example, USDA’s Animal and Plant Health Inspection Service
(APHIS) is responsible for protecting plant and animal resources from domestic and foreign pests
and diseases. The Department of Homeland Security (DHS) is responsible for coordinating
agencies’ food security activities, including border inspections by DHS’s U.S. Customs and
Border Protection (CBP). Other federal agencies—such as USDA’s Agricultural Marketing
Service (AMS) and the National Marine Fisheries Service at the National Oceanic and

11 For more background information, see CRS Report RS22600, The Federal Food Safety System: A Primer.
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Atmospheric Administration (NOAA)—are involved in various food quality and inspection
programs.12
FDA Systems Recognition Assessment Versus FSIS Equivalence Determination
Globally, there is substantial variation in the robustness of food safety systems, according to FDA, ranging from
systems in the early stages of development to highly mature food safety systems. This variability presents a
challenge to U.S. food safety regulators at both FDA and FSIS providing assurances of the safety of food and feed
imported to the United States from foreign countries.
Statutory and regulatory differences governing FDA and FSIS, along with differences in the types of products and
scale of imports shipped to the United States under each agency’s jurisdiction, has resulted in two distinctly
different approaches between FDA and FSIS when assessing the safety of imported food and feed.
FDA Systems Recognition Assessment
Fol owing enactment of the FDA Food Safety Modernization Act (FSMA), FDA considered a range of
approaches for assessing the safety of imported foods obtained from recognized food systems or countries
with an equivalent system to that in the United States. FDA’s systems recognition assessment refers to the
process used by the agency to assess the capability of foreign food safety systems to help ensure the safety
of foods produced under the oversight of that country’s food safety authority/authorities. This process also
provides a means for FDA to establish closer regulatory partnerships and leverage work conducted by FDA
and foreign food safety authorities. As part of this process, FDA relies on information obtained from facility
registrations, border examinations, foreign facility inspections, and import certificates, among other
information.
For more information, see FDA, “Frequently Asked Questions on Systems Recognition for Foreign
Governments,” https://www.fda.gov/food/international-interagency-coordination/frequently-asked-
questions-systems-recognition-foreign-governments.
FSIS Equivalence Determination
At FSIS, equivalence refers to the process of determining whether a country’s food safety inspection system
achieves an FSIS-appropriate level of public health protection as applied domestically in the United States
and provides “standards equivalent to the FSIS to ensure other non-food safety requirements (such as
humane handling, accurate labeling, and assurance that meat, poultry, or egg products are not economically
adulterated) are met.” The country is not required to develop and implement the same procedures as
those in the United States, but rather the country must objectively demonstrate how its procedures meet
U.S. levels of protection. Countries wishing to become eligible to export meat, poultry, or egg products to
the United States must demonstrate that they have a regulatory food safety inspection system that is
equivalent to that of the United States.
For more information, see FSIS, “Equivalence Process Overview,” https://www.fsis.usda.gov/wps/
portal/fsis/topics/international-affairs/Equivalence/equivalence-process-overview.
Both of these approaches comply with U.S. international commitments and obligations under the WTO
Agreement on the Application of Sanitary and Phytosanitary Measures, under which countries may adopt and
enforce public health and safety measures “necessary to protect human, animal or plant life or health,” so long as
such measures are not applied in an arbitrary or discriminatory manner.
The following focuses on the role of federal agencies only and does not discuss the role of state
and local authorities, which reportedly account for as much as 90% of all the food inspections in
the United States through their routine sampling, inspection, and food testing work.13

12 Guidance and information for importers and foreign suppliers who wish to ship food products into the United States
is available from FDA (https://www.fda.gov/food/food-imports-exports/importing-food-products-united-states), FSIS
(https://www.usda.gov/topics/trade/importing-goods; https://www.fsis.usda.gov/wps/portal/fsis/topics/international-
affairs/importing-products), APHIS (https://www.aphis.usda.gov/aphis/ourfocus/importexport), and CBP
(https://help.cbp.gov/s/article/Article-83?language=en_US). The Automated Commercial Environment is the “single
window” electronic system that went into effect in 2016, per Executive Order 13659, Streamlining the Export/Import
Process for America’s Businesses (79 Federal Register 4263, January 24, 2014).
13 Food Chemical News, “FSVP to Change Not Only FDA, but States’ Role in Regulating Imports,” June 23, 2017.
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Food and Drug Administration
FDA’s food regulatory authority comes chiefly from the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended (21 U.S.C. §301 et seq.). FFDCA requires, among other things, that all
domestic and foreign food manufacturing facilities adhere to FDA’s requirements for Current
Good Manufacturing Practices (CGMPs)14 and prohibits the adulteration and misbranding of
food.15 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(Bioterrorism Act, P.L. 107-188) amended FFDCA to require that all domestic and foreign food
facilities register with FDA. The Bioterrorism Act also imposed prior notification requirements
for FDA-regulated imported foods, as well as requirements for maintenance and submission of
records sufficient to identify the immediate supplier and subsequent recipient of these products.16
Congress further amended the FFDCA in 2010 by passing a comprehensive food safety law, the
FDA Food Safety Modernization Act (FSMA, P.L. 111-353), which gave FDA new tools and
authorities to ensure imported food and feed meet the same safety standards as food and feed
produced in the United States.17 For example, FSMA amended the FFDCA to require that all
high-risk domestic facilities be inspected within five years of the law’s enactment and at least
once every three years after that.18 FSMA also authorized FDA to suspend food facility
registrations if there is reasonable probability of the food causing illness or death to humans or
animals.19 Pursuant to FSMA, FDA implemented regulations covering all domestic and foreign
food manufacturing facilities, as well as certain farming operations. FSMA Title III specifically
addressed imported foods, tightening general inspection and administrative requirements
regarding imports. FSMA’s import provisions are described in more detail in the sections below.
More than 300,000 domestic and foreign food facilities are registered with FDA.20 Of the total
number of registered FDA-regulated facilities, about 88,000 are U.S.-based facilities and another
212,000 are foreign facilities that are potentially subject to FDA inspection and reporting
requirements.21
Table 5 provides a summary of available data regarding FDA-regulated imported food and feed
for selected years from FY2010 through FY2018.
Of the more than 212,000 foreign food facilities that are potentially subject to FDA inspection
and reporting requirements, more than 15% are located in the European Union.22 Japan is the
single country with the most number of foreign facilities registered to ship food products into the
United States, with close to 7% of registered facilities. Another 5% of registered foreign facilities

14 21 C.F.R. Part 110. Exempt are establishments such as farms engaged solely in harvesting, storing, or distributing
raw agricultural commodities normally cleaned or otherwise treated before consumption.
15 21 U.S.C. §§301(a)-(c), 342, & 343.
16 21 U.S.C. §350d and 21 U.S.C. §381(m). Regulations are at Title 21, Part 1, Subpart I, of the Code of Federal
Regulations
. FSMA further expanded prior notice requirements for food imports (FSMA §304).
17 FSMA further applies to ingredient suppliers of dietary supplements. FFDCA Section 201(ff) (21 U.S.C. §321(ff))
states that dietary supplements are deemed to be foods, aside from a few exceptions.
18 21 U.S.C. §350j(a)(2).
19 21 U.S.C. §350d(b).
20 FDA, “Registration Statistics” (as of February 2016), http://www.fda.gov/food/guidanceregulation/
foodfacilityregistration/ucm236512.htm. More recent data are not available.
21 In 2012, FDA’s registration renewal removed foreign facilities that had ceased operations, even though their
registration had remained in FDA’s system. This resulted in substantial changes in the reported data over the period.
(Based on CRS communication with FDA, September 5, 2014.)
22 FDA, “Registration Statistics,” http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm.
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are located in China, with another 6% of facilities located in other Asian nations, including South
Korea, India, Taiwan, Vietnam, and Thailand. Nearly 8% are located in Mexico and Canada.
FDA has 13 foreign offices intended to enable FDA staff and U.S. border officials to make
informed decisions about products entering the United States. Foreign offices are located in China
(posts in Beijing, Shanghai, and Guangzhou); India (posts in New Delhi and Mumbai); Latin
America (posts in San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico); Europe
(posts in Brussels, Belgium; London, UK; and Parma, Italy); South Africa (Pretoria); and Jordan
(Amman).23 Decisions to establish a foreign post are based on the volume of imported products
and the magnitude of problems associated with imported products, among other factors. FDA in-
country activities include conducting foreign inspections, assisting foreign governments and
industry to understand FDA standards and requirements, and obtaining information about
products destined for the United States.24
Table 5. FDA Food Safety Inspections of Imported Foods, FY2010-FY2018
FY2010 FY2012 FY2014 FY2015 FY2016 FY2017 FY2018 FY2019

FDA-Regulated Foreign Facilities
254,088 285,977
NA 212,183
NA
NA
NA
NA
Foreign Inspections
354
1,347
1,339
1,357
1,269
1,548
1,638
1,747
Import Physical Exam Subtotal
200,766 201,749 207,764 266,932 276,502 252,903 206,656 159,675
Import Field Exams/Tests
170,392 171,783 183,224 245,804 252,766 229,129 185,761 141,905
Import Lab Samples Analyzed
30,374
29,966
24,540
21,128
23,736
23,774 20,895 17,770
Import Line Decisions (million)
9.7
10.8
12.2
13.1
14.0
15.3
16.9
17.7
% Lines Physically Examined
2.06%
1.87%
1.71%
2.04%
1.98%
1.66%
1.23%
0.9%
Prior Notice Reviews
81,618
81,888
82,821
80,990
87,817
81,035 84,113 80,013
FDA Import (Line) Refusals
17,080
16,386
15,709
15,223
NA
NA
NA
NA
% Refusals (Total Import Decisions)
0.18%
0.15%
0.13%
0.12%
NA
NA
NA
NA
Source: CRS from various sources. The number of FDA-regulated facilities is from FDA, “Registration
Statistics,” http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm. Inspections data
are from FDA Congressional Justifications (https://www.fda.gov/about-fda/reports/budgets) and updates data for
FY2010-FY2012 reported in FDA, Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices. FDA
import refusals are from J. Bovay, FDA Refusals of Imported Food Products by Country and Category, 2005-2013,
March 2016. Most recent reported available data on the number of FDA-regulated facilities is for February 2016.
Notes: Import lines refers to separate product lines on an entry document of FDA-regulated foods. Prior notice
refers to notification to the FDA that an article of food, including food for animals, is being imported or offered
for import into the United States in advance of the arrival of the article of food at the U.S. border. In 2012,
FDA’s registration renewal removed foreign facilities that had ceased operations, even though their registration
had remained in FDA’s system, resulting in a decrease in the number of registered foreign facilities.
FSMA Provisions Addressing Imports
Concerns about low FDA inspection rates of imported foods and available federal resources to
ensure the safety of these imports were widely highlighted during the debate leading up to

23 FSMA provided the authority for FDA to establish foreign offices related to food and feed (P.L. 111-353, §308).
FDA had requested permission to establish an additional post in Brazil but currently has no plans for additional posts.
24 For more information, see FDA, 2012 Report to Congress on the FDA Foreign Offices, February 2012,
https://www.fda.gov/food/food-safety-modernization-act-fsma/2012-report-congress-fda-foreign-offices.
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Congress’ enactment of FSMA. The Government Accountability Office (GAO) conducted a
number of studies critical of FDA’s food safety oversight of both domestic and imported foods.25
Regarding imported foods, GAO noted FDA’s limited authority to ensure that food imports meet
the same food safety requirements as those for domestically produced foods. GAO also noted
FDA’s limited authority to take certain enforcement actions as well as a number of resource gaps
involving border inspections of imported foods and that federal law provided limited authority for
FDA to inspect foreign facilities. FDA only periodically visited foreign facilities to inspect their
operations, usually in response to a concern and only with the permission of the foreign
government.26 Widely cited estimates indicated that FDA inspected about 1% of the food
imported under its jurisdiction.27 Among the cited reasons for this low incidence in inspections
were limited resources, including too few inspectors covering U.S. ports of entry in the face of
ever-increasing import volumes.28 Moreover, import requirements were mostly voluntary,
according to FDA’s draft guidance on Good Importer Practices. A 2011 report by FDA’s Office
of the Inspector General further indicated that the agency’s guidance for handling recalls of
imported foods prior to FSMA “was not adequate to ensure the safety of the nation’s food supply
because it was not enforceable” and that the recall process did not always operate efficiently and
effectively.29 (For other related background, see “Food Safety Concerns Involving Imports.”)
FSMA was enacted to address these types of concerns and limitations. Leading authorities and
mandates involving imported food and feed under FSMA include the following:30
Importer Accountability and Verification: Established that food importers
have an explicit responsibility to verify that their foreign suppliers have adequate
preventive controls in place to ensure that food for human and animal
consumption meets applicable FDA safety standards.
Third-Party Certification: Provided that qualified third parties can certify that
foreign food facilities comply with U.S. food safety standards. This certification
may be used to facilitate the entry of imports.
Certification for High Risk Foods: Authorized FDA to require that high-risk
imported foods be accompanied by a credible third-party certification or other
assurance of compliance as a condition of entry into the United States.

25 See, for example, GAO, FDA Has Provided Few Details on the Resources and Strategies Needed to Implement Its
Food Protection Plan
(GAO-08-909T; June 2008); Food Safety: Selected Countries’ Systems Can Offer Insights into
Ensuring Import Safety and Responding to Foodborne Illness
(GAO-08-794; June 10, 2008); Food Safety: FDA Could
Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities
(GAO-10-699T;
May 6, 2010); Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of
Imported Food
(GAO-09-873; September 15, 2009); and GAO, Food Safety: Federal Efforts to Ensure the Safety of
Imported Foods Are Inconsistent and Unreliable
(RCED-98-103; April 1998).
26 For example, in 2010, FDA conducted 354 inspections of foreign facilities. This compares to 1,747 foreign facility
inspections in FY2019. See Table 5.
27 GAO, Fundamental Changes Needed to Ensure Safe Food, GAO-02-47T, October 10, 2001.
28 See, for example, testimony of Caroline Smith DeWaal, Center for Science in the Public Interest, before the House
Energy and Commerce Committee’s Subcommittee on Oversight and Investigations, July 17, 2007, and testimony of
Jean Halloran, Consumers Union, before the House Committee on Ways and Means, October 4, 2007.
29 FDA, Office of the Inspector General, Review of the Food and Drug Administration’s Monitoring of Imported Food
Recalls
, A-01-09-01500, June 2011. The review examined recalls of imported foods from July 2007 to June 2008.
30 See, for example, FDA, “Background on the FDA Food Safety Modernization Act,” FSMA Facts, July 2011.
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Authority to Deny Entry: Authorized FDA to refuse entry into the United States
of food from a foreign facility if FDA is denied access by the facility or entry to
the country in which the facility is located.
Aside from provisions that address imported food in FSMA’s Title III, other requirements apply
to imported foods and feed. These include mandatory preventive controls for food facilities and
on-farm production standards under FDA’s Produce Safety Rule that apply to both imported and
domestically produced fruits and vegetables.31 The text box provides a summary of FSMA’s
provisions related to FDA-regulated food and feed imports. The section that follows discusses
selected topics related to imports.
FSMA’s import provisions have been described as a “paradigm” shift for foreign suppliers with
the potential to impact global food trade.32 Since enactment, FSMA has resulted in the
implementation of a series of regulations and reporting requirements for foreign countries, U.S.
importers, and FDA. FSMA placed tighter controls on food imports, set minimum entry
requirements, required certification of imported foods, raised importer accountability, and placed
more responsibility on U.S. trading partners. Some stakeholders have expressed resistance to
FDA’s rulemaking requirements.33
FSMA created the Foreign Supplier Verification Program (FSVP) for importers to verify that
foreign suppliers of food for human and animal consumption provide the same level of food
safety standards and public health protection as required of U.S. companies. Under FSVP,
importers are responsible for developing and maintaining a food safety plan and for conducting
supplier verification activities, as well as implementing corrective actions and maintaining
records. The appropriate verification activities and their frequency vary depending on the food,
the foreign supplier, and the types of control actions. Hazards in a food will be controlled if there
is a reasonable probability that exposure to the hazard will result in “serious adverse health
consequences or death to humans or animals,” which may result in an annual onsite audit of the
foreign supplier.34 Verification activities include onsite auditing, sampling and testing of a food,
review of the foreign supplier’s relevant food safety records, and other activities based on the
evaluation of the risk posed by the food and foreign supplier performance. FDA is able to audit an
importer’s food safety plan and can stop imported food from entering the United States if the plan
and/or its implementation is determined to be inadequate. FDA estimates that FSVP will result in
total average annual costs of $435 million.
FSMA also established the Voluntary Qualified Importer Program (VQIP), a voluntary, fee-based
program for the expedited review and importation of foods from importers who achieve and
maintain a high level of control over the safety and security of their supply chains. By allowing
expedited review to some foreign suppliers, VQIP may help FDA manage the sheer volume of

31 See FDA, https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety. The
National Association of State Departments of Agriculture (NASDA) has also emphasized the need to ensure
appropriate food import activities as part of FDA’s Produce Safety Rule and the need to develop national and regional
information sharing networks and processes on producer audits and inspections, recalls, import alerts, and other
procedures. See NASDA, “Model Produce Safety Implementation Framework” February 22, 2019,
https://s3.amazonaws.com/nasda2/media/NASDA-Model-Produce-Safety-Implementation-Framework_2-22-2019.pdf?
mtime=20190906154302.
32 Comments from Michael Taylor, former FDA Deputy Commissioner for Foods, February 17, 2011. See also B. L.
Booren, “The Relatively Unknown FSMA Rule,” OFWLAW.com blog, April 27, 2017.
33 See, for example, H. Bottemiller, “FDA Releases Two Major Rules to Boost Oversight of Imported Foods,” Food
Safety News, July 26, 2013. See also postings from FDAImports.com blog posts available at
https://www.fdaimports.com/blog/category/food-safety-modernization-act-2/.
34 80 Federal Register 74226-74351, November 27, 2015.
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food imported to the United States each year and free up agency resources to better focus on
high-risk imports. FSMA further required that FDA increase the number of inspections of foreign
facilities it undertakes and established programs for building technical, scientific, and regulatory
food safety capacity in foreign countries.
FSMA Provisions Relating to FDA-Regulated Imported Food and Feed
Section 103 (Hazard Analysis and Risk-Based Preventive Controls): Established mandatory preventive
controls for domestic and foreign food facilities (21 U.S.C. §350g).
Section 105 (Standards for produce safety): Established mandatory science-based, minimum standards for
the safe production and harvesting of fruits and vegetables. Requirements apply to both domestic and foreign
operations (21 U.S.C. §350h).

Section 202 (Laboratory accreditation for analyses of food): Established a program for the testing of food
by accredited laboratories and for FDA to submit a progress report on its implementation of a national food
emergency response laboratory network (21 U.S.C. §350k).

Section 301 (Foreign Supplier Verification Program): Established a foreign supplier verification program
(FSVP) for importers to share responsibility for ensuring safety of imported foods according to types of hazards,
importers, and suppliers (21 U.S.C. §384a). Under FSVP, food importers are required to develop and maintain
systems for verifying that their foreign suppliers are manufacturing or growing food in a manner that provides the
same level of public health protection as required of U.S. companies.

Section 302 (Voluntary Qualified Importer Program): Established a Voluntary Qualified Importer Program
(VQIP) to expedite review and importation of foods from participating importers. Eligibility is limited to, among
other things, importers offering food from certified facilities (21 U.S.C. §384b).

Section 303 (Authority to require import certifications for food): Authorized FDA to require that high-
risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a
condition of entry into the United States (21 U.S.C. §384c).

Section 304 (Prior notice of imported food shipments): Established requirements for submitting prior
notice of imported food, including food for animals (21 U.S.C. §381).

Section 305 (Building capacity of foreign governments with respect to food safety): Required HHS to
develop a comprehensive plan to expand the technical, scientific, and regulatory food safety capacity of foreign
governments and their food industries that export foods to the United States.

Section 306 (Inspection of foreign food facilities): Authorized FDA to enter into agreements with foreign
governments to facilitate inspections of registered foreign facilities and to direct resources to inspections of
foreign facilities, suppliers, and higher risk foods (21 U.S.C. §384c).

Section 307 (Accreditation of third-party auditors): Required HHS to develop model standards and
recognized accreditation bodies to ensure that third-party auditors and audit agents meet such standards to qualify
third-party auditors as accredited auditors (21 U.S.C. §384d).

Section 308 (Foreign FDA offices): Required HHS to submit a report to Congress regarding the selection of
the foreign countries for established FDA offices.

Section 309 (Smuggled food): Required HHS, coordinating with DHS, to develop and implement a strategy to
identify smuggled food and prevent its entry into the United States.
Information on the requirements and implementation status of FDA’s FSMA rules and guidance for industry is available
at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry. For other background,
see CRS Report R43724, Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353).

As of 2020, FDA has mostly completed implementation of many of the requirements under
FSMA pertaining to food and feed imports. FDA’s prior notice requirements became effective
May 30, 2013.35 FSVP regulations were finalized in 2016, and the first compliance dates began in

35 78 Federal Register 32359-32362, May 30, 2013 (Docket Folder FDA-2011-N-0179); 21 C.F.R. 1. See also FDA,
“Guidance for Industry: Prior Notice of Imported Food Questions and Answers,” Edition 3, June 2016,
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May 2017.36 FDA regulations providing for accreditation of third-party certification bodies to
conduct food safety audits of foreign food entities (including registered foreign food facilities)
and to issue food and facility certifications were also finalized in 2015 and became effective in
January 2016.37 FDA’s VQIP guidance was finalized in February 2020.38
FSMA regulations affecting foreign suppliers as well as domestic producers and manufacturers—
including preventive controls for food and feed facilities, producer standards for growers, and
protections against intentional adulteration, among other requirements—have been mostly
implemented. Information on the specific requirements and current implementation status of
FSMA rules and guidance for industry is available at FDA’s website.39
FDA’s 2019 Strategy for the Safety of Imported Food outlines the agency’s approach to ensuring
the safety of food imported into the United States. The strategy focuses on four goals: (1)
ensuring that imports meet U.S. food safety requirements, (2) ensuring that border surveillance
prevents entry of unsafe foods, (3) maintaining a rapid and effective response to unsafe imported
food, and (4) maintaining an “effective and efficient” food import program.40 According to FDA,
ensuring that imported food is as safe as that produced domestically requires foreign facility
inspections, cooperation with international regulatory counterparts through facility systems
recognition, food safety partnerships, and screening and examination (and sampling) at the port of
entry.41
FDA Foreign Facility Inspections
FSMA required that FDA inspect at least 600 foreign food facilities in 2011, doubling each year
for the next five years.42 Two possible responses to what this mandate required have been put
forward. One assumes 600 facility inspections in the base year (FY2011) with the number of
inspections doubling each year, rising to 19,200 inspections in the fifth year (FY2016).43 Some
view this goal as unrealistic.44 An alternative response, as noted by GAO, has FDA inspecting

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-prior-notice-imported-
food-questions-and-answers-edition-3.
36 80 Federal Register 74225-74352, January 26, 2016 (Docket Folder FDA-2011-N-0143); 21 C.F.R. 1, 11, and 111.
See also FDA’s fact sheet at https://www.fda.gov/media/94746/download.
37 80 Federal Register 74569-74667, November 27, 2015 (Docket Folder FDA-2011-N-0146); 21 C.F.R. 1, 11, and 16.
See also FDA’s fact sheet at https://www.fda.gov/media/94753/download.
38 Guidance for Industry: FDA’s Voluntary Qualified Importer Program (Docket Number: FDA-2011-N-0144,
February 2020). See also FDA’s fact sheet at https://www.fda.gov/food/food-safety-modernization-act-fsma/fact-sheet-
final-guidance-industry-fdas-voluntary-qualified-importer-program.
39 See FDA’s website at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry.
40 FDA, Strategy for the Safety of Imported Food, February 2019, https://www.fda.gov/food/importing-food-products-
united-states/fda-strategy-safety-imported-food. FDA’s previous strategy for improving the quality of imports more
broadly focused on developing partnerships with regulatory counterparts, developing international information systems,
increasing data collection and risk-based analysis, and using qualified public and private third-party audits to certify
that food facilities comply with U.S. requirements (FDA, Pathway to Global Product Safety and Quality, June 2011).
41 See, for example, statement by former FDA Commissioner Scott Gottlieb, in a letter to State Agriculture
Commissioners, Secretaries, and Directors, July 31, 2018, https://www.fda.gov/media/114883/download.
42 FSMA, P.L. 111-353, §201. FDA is also required to identify high-risk facilities.
43 This assumes 600 facility inspections in the base year (FY2011); there would have been 1,200 inspections in year 1
(FY2012), 2,400 in year 2 (FY2013), 4,800 in year 3 (FY2014), 9,600 in year 4 (FY2015) and 19,200 in year 5
(FY2016).
44 See, for example, GAO, Additional Actions Needed to Help FDA’s Foreign Offices Ensure Safety of Imported Food,
GAO-15-183, February 27, 2015; and C. Smith DeWaal, “FSMA: Import Rules May Foster Global Food Safety,” Food
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twice the actual (or planned) number of foreign food facilities compared with the previous year,
starting with the roughly 1,000 inspections FDA completed in 2011, reaching a target of at least
twice as many inspections—about 2,000—in 2012 as FDA actually inspected in 2011 and
continuing to double the previous year’s actual inspections through 2016.45 Updated estimates
based on FDA-reported actual inspections data and assuming the approach reported in GAO’s
2015 report are shown in Figure 7, indicating that FDA’s annual inspections of foreign food
establishments have not kept pace with targets set by Congress in FSMA. In FY2019, FDA
conducted 1,747 foreign facility inspections, compared to nearly 3,300 facility inspections that
would have been expected under FSMA under the GAO approach. More than 212,000 foreign
facilities are registered with FDA and are potentially subject to FDA inspection.
Figure 7. Actual versus FSMA-Mandated Inspections of Foreign Food Facilities

Source: CRS, updating data and approach reported in GAO, Additional Actions Needed to Help FDA’s Foreign
Offices Ensure Safety of Imported Food
, GAO-15-183, February 27, 2015.
Notes: Assumes FSMA mandated targets indicate a doubling for FY2012 to 1,998 foreign facility inspections
(from 999 actual inspections in FY2011) and again doubling from FY2012 actual inspections (1,347) to a target of
2,694 inspections for FY2013, and so on.
Compared to the number of foreign facility inspections prior to FSMA, however, the number of
inspections in the wake of FSMA has been higher. Available data indicate that FDA conducted
1,034 inspections of foreign food firms over the seven-year period from FY2001 to FY2007.46 In
FY2010, FDA conducted 354 inspections of foreign facilities, which compares to 1,747 foreign
facility inspections in FY2019 (Table 5).

Safety News, February 14, 2011.
45 See also GAO, Additional Actions Needed. Numbers shown here are updated from those cited in GAO’s report.
46 GAO, FDA Has Provided Few Details on the Resources and Strategies Needed to Implement its Food Protection
Plan
, GAO-08-909T, Appendix I, June 2008. Individual annual totals were 211 (2001), 169 (2002), 148 (2003), 153
(2004), 132 (2005), 125 (2006), and 96 (2007).
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FSMA also required that FDA increase the number of food safety inspectors within the agency
and stated a goal of not fewer than 5,000 staff members by FY2014.47 In FY2019, FDA reports
total actual staffing levels at 3,905 full-time equivalents.48
FDA has continued to experience recruitment challenges in its foreign offices, and inspections by
country may vary. The most recent available data indicate that FDA food facility inspections in
China and India accounted for about one-fifth of all foreign facility inspections.49 Most recent
available data indicate that the average cost of a foreign high-risk food facility inspection is
$23,600 per inspection, according to FDA.50
The cost of recruiting, training, and retaining inspectors, as well as the cost of conducting the
actual inspection of registered facilities (along with continued monitoring and auditing of
registered facilities), represents a resource challenge for both oversight agencies and
policymakers. GAO reports that, according to FDA officials, the cost of inspections is the main
reason that the agency is not keeping pace with the FSMA mandate for foreign food facility
inspections.51 GAO has recommended that FDA revise its approach for assessing the
comparability of a country’s food safety system to one that includes assessing foreign food safety
systems for particular food products and not just a country’s food safety systems as a whole.52 A
2020 report by the National Academies of Sciences, Engineering, and Medicine (NASEM) further
describes strategies to address safety challenges in low- and middle-income countries.53
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has issued a number of warning
letters to foreign facilities that export food to the United States. FDA general warning letters
notify a manufacturer when it has significantly violated FDA regulations, usually by identifying
the violation and making clear that the company must correct the problem.54 In 2019, CFSAN
issued nearly 60 warning letters, of which about one-third were issued to foreign facilities, mostly
regarding imported fish and seafood.
Another tracking measure is FDA’s documentation during inspections conducted by agency staff
and its representatives (so-called Form 438s).55 Under FSMA, food importers are required to
develop and maintain FSVPs for their foreign suppliers. However, according to FDA reports on
FY2019 data based on the number of Form 438s issued, failing to develop an FSVP is the most
commonly cited violation during a FDA food facility inspection (accounting for about two-thirds
of the nearly 440 issued forms).56 Other FSVP-related violations include failing to follow or

47 FSMA, P.L. 111-353, §401. By fiscal year, staff level increases were authorized to a total of not fewer than 4,000
staff members (FY2011); 4,200 staff (FY2012); 4,600 staff (FY2013); and 5,000 staff (FY2014).
48 FDA, FDA Justification if Estimates for Appropriations Committees, FY2021, p. 43.
49 GAO, Additional Actions Needed, Figure 3.
50 FDA, Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices, November 2013
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-reports-studies. Most recent data available.
51 GAO, Additional Actions Needed.
52 GAO, FDA Can Better Oversee Food Imports by Assessing and Leveraging Other Countries’ Oversight Resources,
GAO-12-933, September 28, 2012. Among its recommendations, GAO suggests that FDA’s comparability assessments
adopt certain equivalence measures used by FSIS regarding imported meat and poultry, as well as measures used in the
European Union before specific food products can be imported.
53 NASEM, Stronger Food and Drug Regulatory Systems Abroad, 2020, https://doi.org/10.17226/25651.
54 Warning letters are posted at FDA’s website at https://www.fda.gov/inspections-compliance-enforcement-and-
criminal-investigations/warning-letters/about-warning-and-close-out-letters.
55 FDA, “Inspection Observations,” FY2019 data, https://www.fda.gov/inspections-compliance-enforcement-and-
criminal-investigations/inspection-references/inspection-observations.
56 FSVP violations cover Title 21, Sections 1.500-1.514, of the Code of Federal Regulations.
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maintain the FSVP, failing to translate the FSVP into English when applicable, failing to sign and
date the FSVP upon modification, and failing to make adequate assurances of a supplier’s food
safety under FSVP. FDA cited food facilities for other violations relating to food safety and good
manufacturing practices, including violations for failing to take reasonable measures and
precautions related to personnel practices (21 C.F.R. §117.10), pest control (21 C.F.R.
§117.35(c)), sanitation monitoring (21 C.F.R. §120.6), sanitary operations and plant maintenance
(21 C.F.R. §117.35(a)), and Hazard Analysis and Critical Control Point (HACCP) plan
implementation (21 C.F.R. §123.6(c)).57
FDA Foreign Systems Recognition Assessment
FSMA addressed limitations in FDA’s abilities to inspect foreign food facilities by authorizing
FDA to enter into agreements with foreign governments to inspect registered foreign facilities and
by directing resources to inspections of foreign facilities, suppliers, and food types. When the
FDA inspects a food facility, the agency checks for compliance with Current Good Manufacturing
Practices (CGMPs) and any other applicable food safety regulations. Failure to comply can result
in FDA issuing warning letters, citations, or detentions. Under FSMA, FDA may further
recognize a country’s food safety system as comparable to that in the United States if it provides
similar protections, oversight, and monitoring as U.S. requirements. To assess the capability of
foreign food safety systems, FDA implemented a systems recognition assessment—a process used
by the agency to assess the capability of foreign food safety systems to help ensure the safety of
foods produced under the oversight of that country’s food safety authority/authorities. The
assessment relies on a range of available information, including facility registrations, border
examinations (including testing of samples and compliance), foreign facility inspections, import
certificates, and accredited laboratories, as well as information from in-country export programs,
bilateral agreements, and other systems of recognition or equivalence assessments of foreign food
safety systems.58 Other information is obtained from programs established in FSMA, such as the
FSVP and VQIP, and through third-party certification.59
FDA’s systems recognition assessment further provides a means for FDA to establish closer
regulatory partnerships and leverage work conducted by FDA and foreign food safety authorities.
Available guidance provides information to foreign food facilities subject to FDA’s facility
inspection as well as to foreign governments, as authorized under FFDCA.60
To date, FDA has recognized as being comparable to that in the United States the foreign food
safety regulatory systems of Australia, Canada, and New Zealand.61 Entering into such
agreements with some countries allows FDA to focus its resources on other countries that may
present a relatively greater safety risk. FDA has also entered into international partnerships with

57 FDA, “Inspection Observations,” FY2019 data. See also Food Safety News, “Foreign Supplier Verification Most
Common Violation in FDA Food Facility Inspections,” February 26, 2020.
58 See FDA’s FAQs at https://www.fda.gov/food/international-interagency-coordination/frequently-asked-questions-
systems-recognition-foreign-governments. Previously, FDA used the term comparability assessment to describe the
process of food safety systems evaluation.
59 VQIP was authorized in FSMA Section 302 (21 U.S.C. §384b).
60 21 U.S.C. §384c(b). FDA, “Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or
Foreign Government,” December 2017, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/
draft-guidance-industry-refusal-inspection-foreign-food-establishment-or-foreign-government.
61 As of December 2019. FDA, “International Cooperation on Food Safety,” https://www.fda.gov/food/international-
interagency-coordination/international-cooperation-food-safety#systems_recognition. Alternatively referred to as a
comparability agreement or systems recognition by FDA.
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several counterpart foreign government agencies and international organizations through
Cooperative Arrangements (or Memoranda of Understanding) or through Confidentiality
Commitments. FDA’s partnerships include the countries of the European Union, as well as
Argentina, Australia, Brazil, Canada, Chile, China, India, Israel, Japan, Mexico, New Zealand,
the Philippines, Russia, and Switzerland.62
Technical Assistance for Foreign Food Suppliers
FSMA required FDA to develop a comprehensive plan to expand technical, scientific and
regulatory food safety capacity of foreign governments and their respective food industries in
countries exporting foods to the United States.63 FDA issued its report to Congress in 2013, which
provides a strategic framework for how FDA can expand the technical, scientific, and regulatory
capacity of foreign governments and their food industries as part of its international food safety
capacity-building activities.64 Despite this technical assistance, some foreign food suppliers in
low- and middle-income countries may face challenges meeting user fees associated with
imported foods, especially among smaller-sized suppliers.65 VQIP fees for FY2020 are set at
$16,681 per facility.66 Foreign facility reinspection, recall, and importer reinspection fees are
based on the number of direct hours spent on any actions taken and are assessed at an hourly rate
ranging from $253 to $282, plus any foreign travel costs.67 Costs incurred by third-party
certification entities that are responsible for conducting food safety audits and issuing food and
facility certifications to eligible and registered foreign food facilities that meet U.S. food safety
standards and requirements might also contribute to costs faced by foreign suppliers.68
Food safety regulations and standards are often implemented through a variety of sanitary and
phytosanitary (SPS) measures and other technical regulations—such as testing, registration, and
certification, as well as quality, packaging, and labeling requirements. In certain instances, these
may be considered non-tariff barriers that may restrict trade.69 As Congress has important
legislative, oversight, and advisory responsibilities with respect to U.S. trade negotiations, issues
regarding both tariff and non-tariff barriers to agricultural trade are regularly part of trade policy
considerations.
Differences in food safety regulations and standards between the United States and its trading
partners could, in some cases, heighten trade tensions about potential non-tariff barriers to trade

62 As of December 2019. For more updated information, see FDA, “International Arrangements,” https://www.fda.gov/
international-programs/international-arrangements/cooperative-arrangements.
63 FSMA §305. See also FDA’s website at https://www.fda.gov/food/food-safety-modernization-act-fsma/international-
capacity-building-under-fsma.
64 FDA, Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA), February 2013,
https://www.fda.gov/media/124268/download.
65 See, for example, J. Murphy, “Steep VQIP Fees Likely to Shut Out Small Importers, Says Specialty Food
Association, Food Chemical News, August 17, 2015; and H. Bottemiller, “Food Importers Mobilize to Oppose FDA
Fees,” Food Safety News, August 29, 2011.
66 84 Federal Register 35680-35683, July 24, 2019 (Docket Number: FDA-2019-N-3406). Rates are for FY2020.
67 84 Federal Register 35659-35662, July 27, 2018 (Docket Number: FDA-2018-N-2775). Rates are for FY2019.
68 For more information on the accreditation and annual fees incurred by a certification body, see 84 Federal Register
35395-35398, July 23, 2019 (Docket Number: FDA-2016-N-4119). Rates are for FY2020.
69 For more background, see CRS Report R43450, Sanitary and Phytosanitary (SPS) and Related Non-Tariff Barriers
to Agricultural Trade
. WTO definitions for both non-tariff measures and non-tariff barriers are defined by their
abbreviations at http://www.wto.org/english/thewto_e/glossary_e/glossary_e.htm.
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and result in international trade disputes.70 Food safety regulations and standards in the United
States operate under the constraints of internationally accepted trade rules and norms, including
safety and public health protections addressed in the multilateral Agreement on the Application of
Sanitary and Phytosanitary Measures and the Agreement on Technical Barriers to Trade.71 On the
one hand, the United States itself has questioned whether certain U.S. trading partners are
advancing science-based food safety regulations and standards, particularly those regulations and
standards in some European Union countries. This situation has resulted in longstanding trade
disputes that have had implications for ongoing and prior trade negotiations.72 On the other hand,
some low- and middle-income countries may have difficulty meeting what they perceive as
increasingly complex and costly technical regulations and product standards implemented by
developed-country trading partners, including the United States.73 This could also have
implications for future trade relations.
A 2019 World Bank report further highlights the need for investments in low- and middle-income
countries to enhance global food safety management capacity.74 A 2020 NASEM report also
emphasizes the need for capacity building and improved monitoring in low- and middle-income
countries.75 FDA has a partnership with the Joint Institute for Food Safety and Applied Nutrition
(JIFSAN) to help establish food safety training programs in other countries.76
FDA Inspection of Imported Foods
FFDCA authorizes FDA examination of food and feed products offered for entry into the United
States.77 In addition, CBP regulations authorize FDA employees to examine or take samples of
goods entering the United States that are released for delivery by CBP border agents.78 FSMA
provided FDA with additional authorities regarding inspection and oversight; however, FDA
continues to physically examine about 1% of the total number of food import lines each year—
rates similar to that prior to FSMA.79 FSMA further authorized FDA to require that high-risk

70 For examples of how different food safety requirements may lead to formal trade disputes, see WTO’s website at
https://www.wto.org/english/tratop_e/dispu_e/dispu_agreements_index_e.htm?id=A19.
71 SPS measures refer to laws, regulations, standards, and procedures that governments employ as “necessary to protect
human, animal or plant life or health” from the risks associated with the spread of pests, diseases, or disease-carrying
and causing organisms or from additives, toxins, or contaminants in food, beverages, or feedstuffs. TBT measures in
agriculture include SPS measures and other types of measures related to health and quality standards, testing,
registration, and certification, as well as packaging and labeling requirements.
72 See CRS Report R46241, U.S.-EU Trade Agreement Negotiations: Trade in Food and Agricultural Products.
73 Organisation for Economic Co-operation and Development, Analysis of Non-Tariff Barriers of Concern to
Developing Countries
, June 2005, http://dx.doi.org/10.1787/223281783722. See also S. Henson and R. Loader,
“Barriers to Agricultural Exports from Developing Countries: The Role of Sanitary and Phytosanitary Requirements,”
World Development, vol. 29, no. 1 (2001).
74 S. Jaffee et al., The Safe Food Imperative, World Bank Group, 2019, https://openknowledge.worldbank.org/
bitstream/handle/10986/30568/9781464813450.pdf?sequence=6.
75 NASEM, Stronger Food and Drug Regulatory Systems Abroad, 2020, https://doi.org/10.17226/25651.
76 For more information, see JIFSAN’s website, https://jifsan.umd.edu/.
77 21 U.S.C. §381. FDA, Investigations Operations Manual 2019, Chapter 6—Imports, May 2020,
https://www.fda.gov/media/75256/download. Other information is available at FDA, “Importing Food Products into the
United States,” https://www.fda.gov/food/food-imports-exports/importing-food-products-united-states.
78 Regulations are at Title 19, Section 151.4, of the Code of Federal Regulations. FDA commissions CBP to assist with
examinations and investigations related to prior notice requirements for 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).
79 See also rates cited in GAO, Fundamental Changes Needed to Ensure Safe Food.
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imported foods be accompanied by a credible third-party certification or other assurance of
compliance as a condition of entry into the United States.80
In FY2019, FDA examined more than 17.7 million import lines of FDA-regulated food and feed
and physically examined—through field exams or analyzing samples—an estimated 0.9% of the
total number of food import lines (Table 5). An import line—or entry line—refers to each portion
of an import shipment that is listed as a separate item on an entry document. Items in an import
entry having different tariff descriptions must be listed separately. Each entry line identifies a
unique shipment or lot of a particular food by a particular shipper offered for admission into U.S.
commerce at a particular place in time and furthermore references FDA product codes unique to a
specific product.81
Since FY2010, available data indicate that the percentage of import lines physically examined in
FY2019 reached its lowest point (0.9%, down from 2% in FY2010) before FSMA was enacted.
The total number of import lines requiring a decision by FDA did increase dramatically during
that time, rising from 9.7 million to 17.7 million from FY2010 through FY2019. Over the same
period, the number of import field exams/tests and the number of import laboratory samples
analyzed reportedly dropped (Table 5).
FDA does not randomly sample import shipments for inspection but instead uses a risk-based
prediction algorithm to determine whether shipments should be inspected in the field or a
laboratory. FDA electronically screens all import entries using an automated system known as
Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT), which
helps inspectors determine a shipment’s relative risk and whether it needs closer scrutiny (i.e., a
physical examination and/or testing).82 PREDICT generates a numerical score using a database to
analyze risk-based data, such as information about the product, manufacturers, importer, country
of origin, historical data, lab results, facility inspections, recall events, and natural disasters (e.g.,
whether foods may have been subject to flooding, hot weather, or market conditions that could
contribute to greater risk). If the PREDICT score exceeds an FDA-specified threshold, inspectors
are directed to examine the product.
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. Foreign facilities that manufacture/process, pack, or hold
food must register with FDA unless food from that facility undergoes further processing
(including packaging) by another foreign facility before it is exported to the United States.83
Foreign facilities must also provide notice for imported food shipments into the United States
prior to importation.84 Prior notice is required to enable the food to be inspected at U.S. ports of

80 FSMA §303 (21 U.S.C. §384c).
81 See FDA’s website at https://www.fda.gov/industry/import-program-resources/product-codes-and-product-code-
builder.
82 According to FDA, PREDICT “uses data analytics from the entire life cycle of a product to better identify and target
high-risk products before they enter the country” and “helps field inspectors determine which products pose the greatest
risk and, therefore, should be physically examined.” For more information, see FDA’s website (http://www.fda.gov/
forindustry/importprogram/ucm172743.htm). For recommendations regarding PREDICT, see GAO, FDA’s Targeting
Tool Has Enhanced Screening, but Further Improvements Are Possible
, GAO-16-399, May 26, 2016.
83 Under the Bioterrorism Act, facilities that manufacture, process, pack, or hold food for human or animal
consumption in the United States were required to register with FDA by December 12, 2003 (http://www.fda.gov/food/
guidanceregulation/foodfacilityregistration/default.htm).
84 21 U.S.C. §381(m) [FFDCA §801(m)]. For more information, see FDA’s “Guidance for Industry: Prior Notice of
Imported Food Questions and Answers,” Edition 3.
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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. FSMA specified that prior notice submissions must
include information regarding “any country to which the article has been refused entry.”85 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 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.
In practice, import product inspections are relatively infrequent. Product perishability also
presents a challenge, given that some types of testing services might not be available locally or
may overwhelm locally available sources, especially seasonally during periods of peak
production, requiring samples to be sent elsewhere. At some border facilities, mobile laboratories
may be available.86
In March 2020, Congress passed the Protecting America’s Food and Agriculture Act of 2019 (P.L.
116-122). The law authorizes CBP to hire and train 240 new agricultural inspectors and
technicians, as well as 20 new canine units, to work at different U.S. ports of entry and to conduct
additional border inspections of plants, food, animals and goods entering the United States. While
increased border inspections augment FDA efforts, they do not provide the same type of food
safety oversight provided by in-country foreign facility inspections and audits.
FDA’s Authority to Refuse Import Shipments
FFDCA empowers FDA to refuse entry to any food import if it “appears,” based on a physical
examination or otherwise, to be adulterated, misbranded, or in violation of U.S. law.87 In such
cases, FFDCA generally provides that, with few exceptions, a food article must be refused
admission into the United States “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).”88
FDA actions on suspect imported products may be affected by and implemented through FDA’s
“Import Alerts.”89 An import alert is a notification from FDA to signal field inspectors to pay
special attention to a particular product or a range of products from a particular producer, shipper,
or importer.90 According to FDA, import alerts prevent potentially violative products from being
distributed in the United States and place responsibility on the importer to ensure that the
products imported into the United States are in compliance with FDA laws and regulations.91

85 78 Federal Register 32359-32362, May 30, 2013.
86 FDA, “On the Road Again: FDA’s Mobile Laboratories,” FDA Consumer Health Information, March 2009.
87 21 U.S.C. §381(a), FFDCA §801(a).
88 21 U.S.C. §381(a), FFDCA §801(a). In exercising its oversight, FDA relies on a system of prior notifications by
importers and document reviews at points of entry (ports). Importers must have an entry bond and file a notification for
every shipment.
89 FDA’s import alert database is at http://www.accessdata.fda.gov/cms_ia/default.html. Other information is at FDA’s
Import Alert website (https://www.fda.gov/industry/actions-enforcement/import-alerts#purpose).
90 An alert can be issued for an import from a manufacturer, shipper, grower, geographical area, or country. For other
background, see CRS Report R43609, Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues.
91 See FDA’s website at https://www.fda.gov/industry/actions-enforcement/import-alerts. See also FDA, Regulatory
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Import alerts are also a way for FDA to refuse entry of future shipments of an imported product
that either have or could potentially violate FFDCA without physically examining the product.
Such an action, known as detention without physical examination (DWPE), formerly known as
automatic detention, was developed to address recurrent violations.92 DWPE allows the agency to
detain a product without physically examining it at the time of entry. If the problem or condition
exists on a wide scale, federal inspectors 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) may be detained at the border and refused
admission unless the importer is able to demonstrate that the products are in compliance.93
If FDA decides to detain a regulated product, the agency issues a “Notice of FDA Action”
specifying the nature of the violation to the owner or consignee, who is entitled to an informal
hearing in order to provide testimony regarding the admissibility of the product.94 If the owner
fails to submit evidence that the product is in compliance or fails to submit a plan to bring the
product into compliance, FDA is to issue another notice thereby refusing admission to the
product. At that point, the product then has to be exported or destroyed within 90 days.
FDA has issued import alerts on a range of imported foods, including pet food ingredients,
seafood, and dairy products and ingredients, among other foods.95
FDA’s Import Data Reporting Requirements
Pursuant to FSMA, FDA is required to annually report to Congress and make publicly available
certain information about food facilities and foods imported into the United States, as well as
information about foreign FDA offices.96 Annual reports must include the number of registered
facilities inspected (including the number of high-risk facilities inspected and those scheduled for
inspection but not inspected), the number of registered facilities scheduled for inspection in the
previous fiscal year that FDA did not inspect, and the average cost of FDA facility inspections.97
Annual reports must also provide information about food imports, including the number of import
lines examined/sampled (including those not examined/sampled) and the average cost of import
examination/sampling.98 FDA must also report on the number of foreign offices established and
the number of personnel permanently stationed in each foreign office.99

Procedures Manual, Chapter 9—Import Operations and Actions, December 2017, https://www.fda.gov/media/71776/
download.
92 For more information, see C. Anderson, “Assistance with U.S. FDA’s Detention Without Physical Examination,”
Food Safety magazine, May 21, 2013.
93 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.
94 FDA, https://www.accessdata.fda.gov/scripts/importrefusals/. See also FDA, Regulatory Procedures Manual,
Chapter 9—Import Operations and Actions, December 2017, https://www.fda.gov/media/71776/download.
95 FDA, “Recalls, Market Withdrawals, & Safety Alerts,” http://www.fda.gov/Safety/Recalls/default.htm.
96 21 §U.S.C. 393(h), as amended by P.L. 111-353, §201(b). Elsewhere, Section 1009 of the Food and Drug
Administration Amendments Act of 2007 (P.L. 110-85) required annual reporting on the number and amount of FDA-
regulated food products imported by country and type of food, the number of inspectors and inspections performed, and
aggregated data on inspection findings, including violations and enforcement actions.
97 21 §U.S.C. 393(h)(1)(B)-(F) [FFDCA §1003(h)(1)(B)-(F)].
98 21 §U.S.C. 393(h)(2)(A)-(C) [FFDCA §1003(h)(2)(A)-(C)].
99 21 §U.S.C. 393(h)(3) [FFDCA §1003(h)(3)].
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To date, however, FDA has made public annual reports for three years only, covering 2010, 2011,
and 2012.100 Annual reports are not publicly available for subsequent years. Some of the required
data continue to be reported in public documentation submitted to Congress as part of the annual
appropriations process (i.e., FDA’s congressional budget justifications as shown in Table 5).
FDA’s congressional budget justifications do not include certain data, such as the number of
high-risk facilities inspected (including those scheduled for inspection but not inspected), the
number of registered foreign (and domestic) facilities scheduled for inspection in the previous
fiscal year that FDA did not inspect, and the average cost associated with FDA facility inspections
or import examination and sampling. FDA’s congressional budget justifications also do not
provide annual data on the number of foreign offices and personnel.
Measures of Effectiveness of FSMA Mandates
FDA maintains a Food Safety Dashboard portal to monitor progress and performance toward
achieving key outcomes of FSMA-mandated controls for both domestically produced and
imported foods and to report and analyze key performance data.101 For imported foods, available
data focus on the number of inspections and recall events related to imported human food and
animal food subject to FSVP and FSMA preventive controls.102 Reported inspection data are
based on type of classification and class of recall event. Inspection data cover FY2017-FY2019,
while recall data cover FY2018-FY2019 only.
Currently, FDA’s dashboard tracks outcomes from three of the FSMA rules: preventive controls
for both human food and food for animals and FSVP for imported food. FDA says additional
measures and data will be added to the dashboard in the future.103
Figure 8 and Figure 9 show available data on the number of foreign Preventive Controls (PC)
inspections and the number of FSVP inspections from FY2017 to FY2019. Data are for human
food only (excluding animal food) and shown by outcome, measured in terms of no action
indicated (NAIs), voluntary action indicated (VAIs), or official action indicated (OAIs). In
FY2019, there were 1,139 foreign PC inspections and 869 FSVP inspections.104 VAIs accounted
for about one-fifth (273) of all foreign PC inspections and about two-thirds of all FSVP
inspections of human food (Figure 8 and Figure 9, respectively). Of total foreign inspections in
FY2019, there were six OAIs within foreign PC inspections and seven OAIs within FSVP
inspections of human food. In addition, there were 33 foreign PC inspections of animal food and
another 28 FSVP inspections of animal food.
Reported recall data indicate that there were 81 recalls attributed to imported human foods in
FY2019, of which 36 were Class I recalls and 45 recalls were Class II recalls.105 Four recalls were
attributed to imported animal foods—all Class I recall events.

100 During those years, FDA’s report was compiled within the agency’s Annual Report on Food Facilities, Food
Imports, and FDA Foreign Offices
and last reported in 2013 (https://www.fda.gov/food/food-safety-modernization-act-
fsma/fsma-reports-studies). FDA’s most recent report on the agency’s foreign offices was published in 2012.
101 FDA, “FDA-TRACK: Food Safety Dashboard,” https://www.fda.gov/about-fda/fda-track-agency-wide-program-
performance/fda-track-food-safety-dashboard.
102 FDA, “Imported Food Safety Measures,” https://www.fda.gov/about-fda/fda-track-agency-wide-program-
performance/imported-food-safety-measures.
103 HHS, FDA Justification if Estimates for Appropriations Committees, FY2021, p. 278.
104 Data may not reflect unique inspections (i.e., spanning human and animal food, and facility inspections across
different inspection programs) and cumulative totals may not match data shown in Table 5
105 Includes Class I recalls (where there is a reasonable probability that the use of or exposure to a violative product will
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U.S. Food and Agricultural Imports: Safeguards and Selected Issues

Figure 8. Foreign Preventive Controls
Figure 9. Foreign Supplier Verification
Inspections (FY2017-FY2019)
Program Inspections (FY2017-FY2019)


Source: FDA-TRACK: Food Safety Dashboard.
Source: FDA-TRACK: Food Safety Dashboard.
Human food (excluding animal food). Blue = NAI
Human food (excluding animal food). Blue = NAI
(no action indicated); yellow = VAI (voluntary
(no action indicated); yellow = VAI (voluntary
action indicated); red = OAI (official action
action indicated); red = OAI (official action
indicated).
indicated).
USDA, Food Safety and Inspection Service
FSIS regulates the safety and labeling of most domestic and imported meat, poultry, and egg
products under the Federal Meat Inspection Act (FMIA) as amended (21 U.S.C. §601 et seq.), the
Poultry Products Inspection Act (PPIA) as amended (21 U.S.C. §451 et seq.), and the Egg
Products Inspection Act (EPIA, 21 U.S.C. §1031, et seq.).106 FMIA, as amended, requires USDA
to inspect all cattle, sheep, swine, goats, horses, mules, and other equines slaughtered and
processed for human consumption. PPIA, 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,107 and squab [pigeons up to one month old]) intended for use as
human food. EPIA, as amended, provides USDA authority to inspect liquid, frozen, and dried egg
products. Each of these laws also contains provisions governing USDA’s authority to label food
products under its jurisdiction.108 In addition, under the authority of the Agricultural Marketing

cause serious adverse health consequences or death) and Class II recalls (where use of or exposure to a violative
product may cause temporary or medically reversible adverse health consequences, or where the probability of serious
adverse health consequences is remote).
106 FSIS inspects the major red meat and poultry species and their products; catfish was added to FSIS’s responsibilities
by the 2008 farm bill (P.L. 110-246; §11016). FDA has jurisdiction over all meat and poultry not inspected by FSIS.
The agencies share responsibility for egg safety, under , as amended. FSIS covers processed egg products; FDA covers
most whole eggs.
107 Ratites includes flightless birds such as emu, ostrich, and rhea.
108 “A Guide to Federal Food Labeling Requirements for Meat, Poultry, and Egg Products,” prepared for FSIS by
Hogan and Hartson, August 2007, http://www.fsis.usda.gov/wps/wcm/connect/f4af7c74-2b9f-4484-bb16-
fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.
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Act of 1946, as amended, FSIS may provide voluntary inspection for buffalo, antelope, reindeer,
elk, migratory waterfowl, game birds, and rabbits. These meat and poultry species are still within
the purview of FDA under FFDCA, whether or not inspected under the voluntary FSIS program.
The 2008 and 2014 farm bills further required that FSIS inspect and grade farmed catfish
(Siluriformes) products.109
FSIS Foreign Facility Inspection
Under the laws governing FSIS, inspectors are to be present at all times in slaughter plants and
for at least part of each day in establishments that further process meat and poultry products. 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 applicable laws. Inspectors
monitor operations, check sanitary conditions, examine ingredient levels and packaging, review
records, verify food safety plans,110 and conduct statistical sampling and testing of products for
pathogens and residues during their inspections.111 They are to examine all animals destined for
human food both before and after slaughter and ensure that plants are operating in a sanitary
manner under an FSIS-approved safety plan.112 FSIS is also responsible for determining the
equivalence of other countries’ safeguards, and a foreign plant cannot ship products to the United
States unless the agency has determined that the country in which it is located has a meat and/or
poultry program that provides a level of protection that is at least equivalent to the U.S. system.
FSIS Inspection System Equivalency Determination
For imported product, FSIS is responsible for certifying that foreign meat and poultry plants are
operating under an inspection system that is equivalent to the U.S. system before they can export
their product to the United States. As part of its responsibility for determining the equivalence of
another country’s inspection system, FSIS visits the exporting country to review its rules and
regulations, meets with foreign officials, and accompanies them on visits to establishments. FSIS
conducts a document review that focuses on sanitation controls, animal disease controls, slaughter
and processing controls, residue controls, and enforcement controls.113 FSIS also conducts an on-
site audit that assesses these five risk areas and verifies other aspects of a country’s inspection
system, including plant facilities and equipment, laboratories, training programs, and in-plant

109 FSIS was authorized to inspect farmed catfish products under a 2008 farm bill provision (P.L. 110-246, §11016).
The 2014 farm bill (P.L. 113-79, §12106) reconfirmed this provision and also mandated USDA and FDA enter into an
agreement to improve interagency cooperation and prevent duplication; see MOU 225-14-0009 (between FSIS and
FDA), http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/
ucm396294.htm. FSIS promulgated final regulations in December 2015 (80 Federal Register 75590-75630, December
2, 2015).
110 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. It must also document and
maintain records.
111 For more information, see CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
112 For more general information on U.S. meat inspection requirements, see CRS Report RL32922, Meat and Poultry
Inspection: Background and Selected Issues
.
113 FSIS, “FSIS Import Procedures for Meat, Poultry and Egg Products,” https://www.fsis.usda.gov/wps/portal/fsis/
topics/food-safety-education/get-answers/food-safety-fact-sheets/production-and-inspection/fsis-import-procedures-for-
meat-poultry-and-egg-products/fsis-import-procedures.
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inspection operations. If FSIS deems the inspection system to be equivalent to the U.S. system,
USDA publishes its findings and intent in a proposed rule in the Federal Register. After
consideration of public comments, FSIS issues a final decision on the country’s eligibility. Once a
foreign country’s inspection system has been approved, FSIS relies on that government to certify
the eligibility of individual exporting establishments, to inspect them, and to provide annual re-
certification documentation. FSIS periodically reviews foreign government documents and
conducts on-site audits at least annually to verify an eligible country’s inspection system to
ensure that it continues to be equivalent to the U.S. system. No foreign plant is authorized to ship
meat or poultry to the United States unless the country where it is located has received such an
FSIS determination.
FSIS Reinspection of Imported Food
At the U.S. port of entry, an FSIS import inspector is to reinspect all meat and poultry shipments
before shipments are allowed entry to ensure that foreign countries have maintained equivalent
inspection systems.114 Meat and poultry imports are to be 100% visually inspected for appearance
and condition and checked for certification and label compliance. Physical inspections of imports
may be more random.
At the port of entry, once a product shipment of meat or poultry has cleared the CBP and APHIS
requirements, all product shipments must be presented to FSIS for routine reinspection at an
approved import inspection facility. FSIS first is to verify that the product is from an eligible
country and certified establishment.115 All imported product shipments presented for inspection
receive a routine reinspection for general condition, labeling, proper certification, and accurate
count. Reinspections may include a physical examination of the product for visible defects or a
collection of samples for microbiological, food chemistry, drug, or chemical residue analysis.
Product shipments are then randomly selected for an additional reinspection based on the volume
imported from the country within each category. Products that pass reinspection are considered
accepted for entry into the United States. Products that fail reinspection are to be refused entry
and must be re-exported, converted to non-human food, or destroyed. This automatically results
in an intensified rate of reinspection for future shipments of like product from the same
establishment.
FSIS currently reinspects imported meat (including Siluriformes), poultry (including ratite), and
egg products at about 1,300 eligible foreign establishments in nearly 40 countries.116 Eligible
countries include many of the countries of the European Union, as well as Argentina, Australia,
Brazil, Canada, Chile, Costa Rica, Honduras, Iceland, Israel, Japan, Mexico, Namibia, New
Zealand, Nicaragua, China, South Korea, San Marino, Thailand, Uruguay, and Vietnam. 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.
In FY2019, a reported 3,954 million pounds of imported meat and poultry products and a
reported 7.5 million pounds of imported egg products were presented to USDA for reinspection
(Table 6).

114 FSIS, “FSIS Import Procedures for Meat, Poultry and Egg Products.” About 65 FSIS inspectors carry out
reinspection at approximately 150 official import establishments.
115 If the foreign country or the foreign establishment that produced the product is not eligible to export to the United
States, the shipment is to be refused entry.
116 FSIS, “Eligible Foreign Establishments,” https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/
importing-products/eligible-countries-products-foreign-establishments/eligible-foreign-establishments.
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Table 6. Imported Meat, Poultry, Egg Product Reinspection and Refusal, 2005-2019

Meat and Poultry Products
Egg Products
Presented Refused/Rejected
Rate
Presented
Refused/Rejected
Rate

Fiscal Year
(1,000 pounds)
(%)
(1,000 pounds)
(%)
FY2005
4,303,345
9,207
0.21%
N/A
N/A
N/A
FY2006
3,888,188
11,624
0.30%
N/A
N/A
N/A
FY2007
3,398,480
6,602
0.19%
N/A
N/A
N/A
FY2008
3,273,517
11,624
0.36%
21,758
48
0.22%
FY2009
3,398,480
6,602
0.19%
19,371
0
0.00%
FY2010
3,210,034
9,297
0.29%
22,435
0
0.00%
FY2011
2,900,139
5,536
0.19%
18,471
50
0.27%
FY2012
3,066,627
4,859
0.16%
16,128
0
0.00%
FY2013
3,141,960
4,744
0.15%
10,227
<1
0.00%
FY2014
3,575,728
3,881
0.11%
24,503
39
0.16%
FY2015
4,442,517
5,082
0.11%
14,593
86
0.59%
FY2016
4,148,379
6,572
0.16%
22,449
63
0.28%
FY2017
4,064,517
11,993
0.30%
12,490
23
0.18%
FY2018
4,366,648
5,689
0.13%
9,473
36
0.38%
FY2019
3,953,922
5,327
0.13%
7,518
5
0.07%
Source: CRS from various FSIS Quarterly Enforcement Reports, http://www.fsis.usda.gov/wps/portal/fsis/topics/
regulatory-compliance/regulatory-enforcement/quarterly-enforcement-reports. FY data (October 1 through
September 30). N/A = not available.
Notes: Annual totals are in the quarterly report ending September. For more recent years, see meat and
poultry products (Table 3a) and egg products (Table 3b). Rejected/Refused Entry reflect the difference between
imported products refused entry excluding refused products that were subsequently rectified.
FSIS’s Authority to Refuse Import Shipments
FMIA and PPIA 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; PPIA, 21 U.S.C. §457).117 Similar to FFDCA, both FMIA and PPIA disallow “prohibited”
acts involving products 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

117 FSIS regulations are at Title 9, Section 300, of the Code of Federal Regulations. For meat products, labeling
regulations are at Title 9, Section 317; for poultry, regulations are at Title 9, Section 381. Regulations regarding
weights are at Title 9, Section 442. Other information on FSIS labeling requirements is at http://www.aamp.com/
regulations/fsis-labeling/.
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for sale under the name of another food,” or are “an imitation of another food, unless its label
bears a statement to that effect, 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 is one that bears or contains any “poisonous or deleterious
substance which may render it injurious to health” or otherwise poses a risk to consumer health.
Food Safety Concerns Involving Imports
A number of high profile food safety-related incidents and outbreaks involving imported foods
have generated growing concerns about whether current federal programs sufficiently ensure the
safety of U.S. food imports.118 Several large multi-state outbreaks have been linked to foods
regulated by both FDA and USDA.
Attention focused on the safety of food imports in 2007 when pet food ingredients imported from
China, contaminated with the chemical melamine, sickened or killed an unknown number of dogs
and cats and contaminated some livestock feeds. Then, in 2008, melamine contamination of
infant formula in China sickened thousands of children and raised concerns about the safety of
infant formula in the United States and elsewhere. Also in 2008, more than 1,400 persons were
infected with an unusual strain of bacteria, Salmonella Saintpaul. Officials first suspected fresh
tomatoes, but later tests found the pathogen in serrano peppers and irrigation water from a farm in
Mexico. Other foodborne illness outbreaks have involved imported fish and seafood and fruits
and vegetables, among other products. These incidents highlighted the limited reach of
government oversight of U.S. food imports but have also highlighted the difficulty in tracing the
many pathways taken by a common food ingredient as well as the frequent confluence of human
and animal food ingredients. An Interagency Working Group submitted a report to the President
in 2007 further highlighting the need to foster compliance with U.S. safety standards through
enhanced certification; encourage improved importer practices, transparency, and information
exchange; strengthen penalties for noncompliance; and increase U.S. presence overseas and
training for foreign inspection agencies.119 Additional recommendations include those in a 2010
report by the NASEM.120 A series of Senate hearings in 1998 had earlier highlighted “weaknesses
in federal agencies’ control over shipments of imported foods that allow unsafe foods to enter
domestic commerce.”121
Public concerns about foodborne illness incidents contributed to Congress enacting FSMA in
2010. Despite the implementation of preventive controls and other standards involving both
imported and domestically produced foods as part of FSMA, foodborne illness incidents
involving imported foods have continued to be of particular concern. Import alerts targeting

118 The Centers for Disease Control and Prevention (CDC) defines a “foodborne disease outbreak” as occurring when
two or more people get the same illness from the same contaminated food or drink.
119 White House Office of the Press Secretary, Import Safety Action Plan: Increasing Protection of American
Consumers
, November 6, 2007. A report to the President by the Interagency Working Group on Import Safety is
available at https://2001-2009.state.gov/e/eeb/rls/fs/2007/94675.htm.
120 NASEM, Food Safety: The Role of the Food and Drug Administration, Appendix E (The U.S. Food and Drug
Administration and Imported Food Safety), 2010, pp. 483-488, https://doi.org/10.17226/12892. Recommendations
included the following: establish a tiered food import monitoring system and base examination/sampling rates on risk
and in-country information; establish an importer licensing program; give priority to negotiating agreements with
countries that have comparable food safety systems; require fees for safety inspections; provide technical capacity
assistance to foreign suppliers; provide recognition of third-party audits of firms (by accredited certifying bodies);
require import certification for some food products; and provide additional training and inspection resources.
121 Hearing on “The Safety of Food Imports” before the Permanent Subcommittee on Investigations of the Committee
on Governmental Affairs, 115th Congress, 2nd Session (S. Hrg. 105-516), September 1998.
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adulterated products, including pet food ingredients, farmed seafood, and other food products and
ingredients from China have continued.122
While attention has tended to focus on the safety of imported foods, it is unclear whether
imported foods pose any greater safety risk than domestically produced foods.123 Available data
regarding foodborne illness outbreak investigations do not readily identify whether a food is
domestic or foreign sourced.124 Although available data on FDA and USDA import refusals may
reveal recurring problems in certain types of imported foods, these data do not indicate the actual
level or distribution of food safety risk. In part, this is attributable to the process for selecting
shipments for inspection and for other types of administrative actions. Namely, the selection
process for deciding which imports to inspect is not random but instead uses a risk-based
approach to set sample size. Consequently, analysis of U.S. import refusals due to food safety
violations highlight food safety problems that appear to recur in trade and where FDA has
focused monitoring efforts.125 Furthermore, analysis of available foodborne outbreak and import
refusal data does not take into account the quantitative increase in the volume of food imports.126
Higher relative numbers of refusals do not necessarily indicate that one country’s products are
less safe or that its food safety system is less rigorous than that of another country. The country
simply might be a more important source of U.S. agricultural and/or seafood products. For
example, Mexico is among the leading countries in terms of numbers of refused shipments, but it
is also the single largest exporter of agricultural products to the United States. Given the diversity
of traded products and the available data, however, it is difficult to compare foreign food
suppliers on food safety in a meaningful way.
In some cases, import violations appear to be relatively more prevalent involving products
originating from low- and middle-income countries. For example, one study showed that there
were 605 violations per billion dollars of trade (1998-2004) involving products originating from
low- and middle-income countries compared to 134 over the same period among products
originating from high-income countries.127
Global sourcing and related supply chain complexities in the U.S. food system (text box) further
complicate the efforts of federal and state authorities to effectively respond to food safety threats.

122 For information on recent FDA import alerts, see FDA, Import Refusal Report data files,
https://www.accessdata.fda.gov/scripts/importrefusals/.
123 For example, comments by CDC and industry presenters at the Food Safety Research Consortium and the
University of Florida Emerging Pathogens Institute’s Workshop, Assuring Safety of Imported Food: Public and Private
Roles in a Risk-Based System
, February 1-2, 2010.
124 For example, CDC, National Outbreak Reporting System (NORS), https://wwwn.cdc.gov/norsdashboard/; or FDA,
“Outbreaks of Foodborne Illness,” https://www.fda.gov/food/recalls-outbreaks-emergencies/.
125 For additional discussion, see C. Buzby et al., Food Safety and Imports: An Analysis of FDA Food-Related Import
Refusal Reports
(EIB-39), ERS, September 2008, p. iii.
126 D. Flynn, “More Imported Food Isn’t More Dangerous, Attorneys Say,” Food Safety News, March 28, 2017.
127 See, for example, L. Unnevehr, “Information Needs for Creating Incentives in Global Supply Chains,” presentation
at Assuring Safety of Imported Food.
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Global Sourcing and Supply Chain Complexity
A number of factors are shaping current competitive market and trade conditions worldwide and contributing to
overall trends in global food trade. In general, these include:

a relatively open U.S. import regime and lower average import tariffs, with products from most leading
suppliers entering the U.S. duty-free or at preferential duty rates;

relatively low U.S. non-tariff trade barriers—such as restrictive import and inspection requirements, technical
product standards, and sanitary and phytosanitary (SPS) requirements—on imported foods;

opportunities to import foods outside the U.S. production window (referred to as counter-seasonal trade),
such as fruit and vegetable supplies from Southern Hemisphere countries during winter months in the United
States, driven, in part, by increased domestic and year-round demand by U.S. consumers;

consumer demand for specialty foods, such as European cheese and wine or Southeast Asian spices or other
international specialty products, including tropical products not commonly grown in the United States;

competition and supplies from relatively low-cost or subsidized production in some countries; and

other market factors, such as exchange rate fluctuations and structural changes in the U.S. food industry and
production efficiencies associated with global sourcing, as well as increased U.S. overseas investment and
diversification in market sourcing by U.S. companies.
These trends have contributed to considerable supply chain complexities worldwide. A 2012 NASEM report
highlights the so-called “Well Traveled Salad,” il ustrating a salad composed of 10 ingredients said to potentially
originate in nearly 40 countries.
The report highlights how
complexity in food sourcing
has the potential to create
“conditions favorable for
emergence, reemergence,
and spread of food-borne
pathogens” compounded by
the “challenge of
anticipating, detecting, and
effectively responding to
food-borne threats to
health.”
Multiple ingredients and
inputs are sourced from a
wide range of countries,
both individually sourced
products and ingredients
between individual food
companies and importing
countries as well as
internally sourced products
from foreign-owned entities within a larger multinational company (such as global sourcing between parent and
subsidiary). The report asserts that such complexity, compounded by sourcing from many individual producers and
various food business management systems (input suppliers, service providers, producers, processors,
manufacturers, distributors, retailers, foodservice, etc.) makes it difficult to trace the source of contamination if
and/or when it might occur. This is especial y true regarding certain highly processed foods with multiple
ingredients and inputs from multiple suppliers. Further complicating this process, according to the NASEM report,
is often overlapping and/or inconsistent policies and goals among governments and private sector initiatives, as well
as lack of clear guidance by international food safety and health organizations.
Among its conclusions, the report observes that as the volume of imports continues to steadily increase, in part
given increased globalization and rising consumer demand for a wider variety of foods year-round, so do concerns
about the safety of imported foods. The report contends that the sheer volume of imported foods annually strains
the ability of federal resources to inspect incoming foods at the border.
For more information, see NASEM, Improving Food Safety Through a One Health Approach: Workshop Summary, 2012,
http://iom.edu/Activities/PublicHealth/MicrobialThreats/2011-DEC-13.aspx. See also NASEM, Stronger Food and Drug
Regulatory Systems Abroad
, 2020, https://doi.org/10.17226/25651.
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Foodborne Outbreaks Involving Imported Foods
Limited available data indicate that imported foods account for a small but growing share of U.S.
foodborne illness outbreaks. A 2017 analysis by researchers at the Centers for Disease Control
and Prevention (CDC) and FDA, using data for 1996-2014, found that “outbreaks associated with
imported foods represented an increasing proportion of all foodborne disease outbreaks where a
food was implicated and reported.”128 During 1996-2000, 1% of U.S. outbreaks were associated
with imported foods, which compares to 5% during 2009-2014 (Figure 10). Outbreaks associated
with an imported food increased from an average of three per year (1996-2000) to an average of
18 per year (2009-2014). From 1996 to 2014, a total of 195 outbreak investigations implicated an
imported food, resulting in an estimated 10,685 illnesses, 1,017 hospitalizations, and 19 deaths.
Figure 10. Number of Outbreaks Caused by Imported Foods and Total Number of
Outbreaks with a Food Reported, United States, 1996-2014

Source: L. H. Gould et al., “Outbreaks of Disease Associated with Food Imported into the United States, 1996-
2014,” Emerging Infectious Diseases, vol. 23, no. 3 (March 2017), pp. 525-528, https://wwwnc.cdc.gov/eid/article/
23/3/16-1462 (doi:10.3201/eid2303.161462).
Notes: Based on a total of 195 outbreak investigations implicating an imported food, resulting in 10,685
il nesses, 1,017 hospitalizations, and 19 deaths (1996-2014).
Fish/seafood and produce were the imported foods most often linked to U.S. foodborne
outbreaks, accounting for an estimated 55% and 33% of outbreaks, respectively. Of all outbreak-
associated illnesses caused by imported foods, fish and seafood accounted for an estimated 11%
of illnesses, while produce accounted for 84% of illnesses. Latin America and the Caribbean was
the most common region of origin for imported foods most often linked to these outbreaks,
followed by Asia. By country of origin, more than 30 countries were implicated during the 2009-
2014 period, with foods from Mexico most frequently associated with U.S. foodborne outbreaks
(42 outbreaks). Other countries associated with more than 10 U.S. outbreaks included Indonesia

128 L. H. Gould et al., “Outbreaks of Disease Associated with Food Imported into the United States, 1996-2014,”
Emerging Infectious Diseases, vol. 23, no. 3 (March 2017), pp. 525-528 (doi:10.3201/eid2303.161462). Available at
https://wwwnc.cdc.gov/eid/article/23/3/16-1462_article. The cited report updates previous CDC analysis of outbreaks
caused by imported foods (2009-2010), https://www.cdc.gov/media/releases/2012/p0314_foodborne.html.
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(17 outbreaks) and Canada (11 outbreaks). Outbreaks associated with imported fish and shellfish
were most commonly imported from Asia (65% of outbreaks associated with fish or shellfish),
while outbreaks associated with imported produce originated mostly from Latin America and the
Caribbean (64% of outbreaks associated with produce).
FDA Import Violations and Shipment Refusals
As part of FDA’s food safety inspection process, the agency inspects imports at the port of entry
for signs of adulteration, misbranding, or other violations.129 For some shipments, FDA may issue
import alerts on food imported from foreign countries that could result in the imported product
being detained and possibly refused entry into the United States. (For a more detailed discussion
of this process, see “FDA’s Authority to Refuse Import Shipments.”)
Data compiled and verified by FDA and reported in a 2016 study by USDA’s Economic Research
Service indicate that adulteration accounted for 57% of all FDA import refusals during the 2005-
2013 period (totaling 80,825 import refusals) (Figure 11). More recent FDA-verified data are not
readily available.130 Based on available FDA-verified data, about half of FDA import refusals due
to adulteration were attributable to other sanitary adulteration, such as filthy or decomposed
appearance or unregistered processes. About one-third of FDA import refusals due to adulteration
were attributable to chemical adulteration (such as unregistered pesticides or other illegal
additives), with the remainder due to pathogens and their toxins (such as Salmonella, Listeria, and
aflatoxins). Misleading or missing labels accounted for another 41% of all FDA import refusals
during the 2005-2013 period (totaling 58,764 import refusals). Another 2% of all FDA import
refusals were attributable to other (not easily classifiable) reasons. Overall, countries with the
most shipments refused over the period were Mexico, India, and China.131
Compared to a previous USDA study covering the 1998-2004 period, USDA’s most recent study
notes that the number of refused shipments declined relative to the volume of imports over the
2005-2013 period.132 It is unclear whether this decrease reflects improvements by foreign
producers, shippers, and importers in complying with U.S. laws or a lower incidence of FDA
inspections and thus fewer detentions and refusals of imported foods, or a combination of both.
Data on FDA import refusals are based on the number of import lines refused, not the volume of
products being rejected either as an absolute quantity or as a proportion of total imports. The
number of import lines does not necessarily equal the number of shipments. In FY2018, FDA
examined more than 16.9 million import lines of FDA-regulated foods.133 The actual number of
import refusals is not available. The rate of violations of FDA-regulated food imports reported by
USDA from 2009 to 2013 of about 0.1% to 0.2% of all import lines examined is the most recent
available (see data excerpted in Table 4). If this rate of refusals continued to be representative in
FY2018, then import refusals that year may have numbered around 16,800.

129 FFDCA prohibits adulterated or misbranded foods in interstate commerce (21 U.S.C. §§331(a), (b), (c), (k)).
130 Actual raw data are available from FDA for the years since 2014 as part of its Import Refusal Report data files
(https://www.accessdata.fda.gov/scripts/importrefusals/). These data often require additional checks and verification
from FDA to remove any duplicate and/or overlapping data. The data files also include other FDA-regulated products:
drugs, medical devices, and vitamins.
131 By 2018 total value, these countries accounted for nearly 40% of the total value of U.S. food imports: Mexico
(27.2%), China (7.5%), and India (4.8%) (Table 2).
132 J. Bovay, FDA Refusals of Imported Food Products by Country and Category, 2005-2013, Table 3, March 2016.
Data for 1998-2004 are from C. Buzby et al., Food Safety and Imports: An Analysis of FDA Food-Related Import
Refusal Reports
(EIB-39), ERS, September 2008.
133 FDA, FDA Justification if Estimates for Appropriations Committees, FY2021, p. 71.
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Figure 11. FDA Import Refusals, by Violation Charges, 2005-2013

Source: CRS from data in J. Bovay, FDA Refusals of Imported Food Products by Country and Category, 2005-2013,
March 2016, Table 3, https://www.ers.usda.gov/webdocs/publications/44066/57014_eib151.pdf. Also see J. Bovay,
“Patterns in FDA Food Import Refusals Highlight Most Frequently Detected Problems,” Amber Waves, 2016.
Notes: USDA/ERS using data from FDA’s OASIS (Operational and Administrative System for Import Support)
database. Based on a total of 142,679 shipment refusals (2005-2013). Data are calendar year. Percentages reflect
share of the total number of FDA import refusals.
Table 7 shows the types of adulteration and mislabeling violations for selected years and totals
for 2005-2013. Adulteration violations involving pathogens, toxins, and chemical contamination
are of particular concern because of their links to foodborne illness in humans. Misbranding and
mislabeling is also a concern given that failure to identify allergens or other undeclared
ingredients may lead to illness and even fatalities in some cases.
Data on FDA import refusals by food group indicate that fish and seafood, vegetables and fruits,
and spices accounted for more than half of all import refusals during 2005-2013 (Figure 12).
Most produce refusals were due to violative residues (such as pesticides); filth, microbial
pathogens, and bacterial contamination (mostly Salmonella); and improper documentation.
Import violations involving produce were mostly from Mexico and other Latin America and
Caribbean nations. Refusals of fish and seafood were attributed to Salmonella and other
pathogens (bacteria), residues (veterinary drugs), filth, and improper process filing. Violations
were found in products from China, Vietnam, India, Bangladesh, and a number of other Asian
nations. Other analysis of U.S. import refusal data showed that more than half of product refusals
from 2002 to 2012 (based on number of consignments) were from Brazil, Russia, India,
Indonesia, China, and South Africa.134 Among the leading products refused entry from these
countries were fish and seafood products, spices, flavorings and salts, and vegetables and
vegetable products. Other research suggests that food import refusals may result in rejected
products being diverted to other export markets.135

134 See, for example, M. Kallummal and H. M. Gurung, “Agriculture Products Imported by United States and SPS
Measures Based Refusals: Impact of Refusals by the FDA of United States on BRIICS Countries,” 2013.
135 See, for example, K. Baylis et al., “Food Import Refusals: Evidence from the European Union,” American Journal
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Compared to USDA’s previous analysis covering the 1998-2004 period, the share of total FDA
refusals of imported vegetables and vegetable products has decreased—from 20.6% of all refusals
(1998-2004) to 16.1% of refusals (2005-2013). The share of FDA refusals of imported spices
increased from 3.8% to 7.7% of all FDA import refusals during the same period (Figure 12).136
Over the 2005-2013 period, adulteration violations accounted for 57% of all violations (compared
with 65% over the 1998-2004 period), while misbranding violations accounted for 41% of
violations (compared with 33% over the previous study period).137 Figure 13 shows the number
of shipment violations due to adulteration by the type of adulteration for selected product
categories. Additional data and accompanying discussion about these violations is available in the
report.
Table 7. Number of Violations, by Selected Charge Code for Selected Years
2005
2010
2012
2013
Total (2005-2013)

Adulteration





Filth/filthy
2,121
1,851
1,918
1,598
16,801
Salmonella
874
1,406
1,350
1,150
11,407
No information on scheduled process field
1,495
1,039
944
705
11,163
Unsafe color additive
961
1,555
923
1,097
10,784
Pesticides
1,117
830
1,678
1,920
10,090
Needs food canning establishment number
993
720
516
414
7,598
Manufactured under insanitary conditions
222
95
780
339
2,213
Insanitary
150
270
404
310
1,974
Unsafe food additive
80
215
153
235
1,718
Veterinary drug residue
74
199
135
123
1,466
Poisonous
109
120
226
184
1,319
Misbranding/Mislabeling





Fails to bear nutrition label
1,035
1,889
1,299
1,401
14,684
No list of ingredients
851
1,088
818
786
8,589
Lacks numerical count label
557
870
640
700
8,123
No English
518
777
583
806
5,934
Labeling
381
386
463
428
3,641
Does not bear usual name
264
328
324
462
3,202
Lacks firm name
318
349
341
322
3,102
Fails to bear artificial color labeling
236
415
293
344
2,984
False or misleading label
119
250
126
176
1,512
Total (excluding “Other” violations)
13,370
16,386
15,709
15,223
142,679
Source: J. Bovay, FDA Refusals of Imported Food Products by Country and Category, 2005-2013, March 2016, Table
5. “Total” includes other shipment refusals not separately listed under each separate “Adulteration” and
Misbranding/Mislabeling category (thus totals do not add).
Notes: Data from FDA’s OASIS (Operational and Administrative System for Import Support) database.

of Agricultural Economics, vol. 93, no. 2 (January 2011), https://doi.org/10.1093/ajae/aaq149.
136 In 2013, FDA released its risk profile, Pathogens and Filth in Spices, detailing 14 spice-related outbreaks worldwide
between 1973 and 2010. The report is available at https://www.fda.gov/food/cfsan-risk-safety-assessments/risk-profile-
pathogen-and-filth-spices.
137 J. Bovay, FDA Refusals of Imported Food Products by Country and Category, 2005-2013, March 2016.
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