Efforts to Address the Safety of FDA-Regulated Food Imports
link to page 1 link to page 1 link to page 2 link to page 2 
May 5, 2016
Efforts to Address the Safety of FDA-Regulated Food Imports
High-profile foodborne outbreaks and incidents involving
Table 1. Import Share of U.S. Food Consumption
imported foods have generated growing concerns about
1993
2003
2013
whether current federal programs sufficiently ensure the
Selected Food Groups
safety of these imports. Safety concerns have been
(percent)
associated with imported products from China, Mexico, and Total consumed food
12.8
16.0
19.4
nations in Central and South America, Southeast Asia,
Europe, and elsewhere. Some imported products that have
Red meat
7.6
9.3
7.4
raised concerns include fish and seafood, fruits and
Poultry/eggs
0.0
0.1
0.4
vegetables, and pet foods. These products fall primarily
Dairy products
1.9
3.6
1.9
under the responsibility of the Food and Drug
Administration (FDA) at the U.S. Department of Health and Fish and shellfish
54.6
82.1
96.6
Human Services and the Food Safety and Inspection
Grains
20.4
13.9
15.5
Service (FSIS) at the U.S. Department of Agriculture
(USDA).
Fruits and nuts
30.3
36.8
48.7
Vegetables
7.9
14.8
20.0
Food imports have been steadily increasing over the past
Sweeteners
16.6
16.7
25.0
decade due to globalization and consumer demand for a
wider variety of foods year-round. By volume, imports rose Spices
75.1
83.5
86.3
nearly 60% (2004 to 2014), driven in part by increased
Source: CRS from USDA data based on volume.
imports of fruits and vegetables and some processed foods
(Figure 1). Imports now account for nearly one-fifth of all
Data on FDA Refusals of Imported Food Products
foods consumed in the United States and an even larger
In recent years, FDA has issued import alerts on a range of
share of consumption of some foods, such as fish and
imported foods, including pet food ingredients, seafood,
seafood (97%) and fruits and nuts (49%), among other
and dairy products and ingredients, among other foods.
products (Table 1).
Data on FDA import refusals by violation type, provided by
FDA, indicate that adulteration accounted for more than
The sheer volume of imported foods each year further
half of all refusals during 2009-2013 (Figure 2). Refusals
complicates efforts to secure the safety of imported foods
result from violations associated with misbranding and/or
and strains an already challenged U.S. food inspection and
adulteration, among other types of violations. Most
oversight system. For foods under FDA’s jurisdiction
adulteration is attributable to pathogens and their toxins
(covering all foods except most meat and poultry products),
(such as Salmonella, Listeria, and aflatoxins), with the
more than 210,000 foreign food facilities are registered
remainder attributable to chemical adulteration (such as
with FDA and are potentially subject to inspection. Each
unregistered pesticides or other illegal additives) and other
year FDA inspects about 25% of domestic food facilities
sanitary adulteration (such as filthy or decomposed
and physically examines about 2% of all food imported
appearance or unregistered processes). Misleading or
during the year. Another 1,200 eligible foreign meat and
missing labels accounted for another 42% of FDA refusals.
poultry establishments fall under USDA’s jurisdiction.
Data on FDA import refusals by food group indicate that
Figure 1. U.S. Food Imports, by Food Group
fish and seafood, vegetables and fruits, and processed snack
foods and baked goods accounted for nearly 60% of all
import refusals during 2009-2013 (Figure 3). Most produce
refusals were due to violative residues (such as pesticides);
filth, microbial pathogens, and bacterial contamination
(mostly Salmonella); and improper process filing. Import
violations were reported to be found in products 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 other Asian nations.
Source: CRS from USDA data. Excludes some product groups.
While attention has focused on the safety of imported
foods, it remains unclear whether imported foods pose any
greater safety risk than domestically produced foods.
https://crsreports.congress.gov
link to page 1
Efforts to Address the Safety of FDA-Regulated Food Imports
Limited available data on foodborne outbreak investigations
oversee quality and grading standards for some foods but
are published by the Centers for Disease Control and
do not strictly play a food safety role. The U.S. Customs
Prevention (CDC) in its Foodborne Outbreak Online
and Border Protection at the Department of Homeland
Database (FOOD) Tool. FOOD data are a small
Security plays an important role regarding food imports as
convenience sample (i.e., not a random sample) of
part of the agency’s overall oversight role at U.S. borders.
outbreaks in the United States each year. Also, outbreaks
account for less than half of all foodborne illnesses each
The FDA Food Safety Modernization Act (FSMA, P.L.
year. CDC has noted that the origin of a food—whether
111-353) includes several provisions on food imports
domestic or imported—is often difficult to determine. The
imposing tighter controls, setting minimum entry
FOOD system does not attempt to capture this information.
requirements, requiring certification of imported foods, and
CDC has previously commented that when it looked
raising importer accountability. FSMA created several new
specifically at outbreaks that were attributed to imported
programs and requirements, including a program for
foods, it found that fish and spices were the imported foods
expedited entry and capacity building in foreign countries.
most often linked to outbreaks (which is consistent with the
Other FSMA requirements establishing preventive controls
import shares of these foods in Table 1). Nearly 45% of the
and standards for produce also apply to both imported and
imported foods causing outbreaks came from Asia.
domestically produced products. FDA has issued final
FSMA regulations, which will be phased in over the next
Figure 2. FDA Import Refusals, by Violation
few years. FSMA’s import requirements place more
responsibility on U.S. trading partners. Some claim that
FSMA requirements could influence food safety efforts
worldwide once implemented. Key import requirements
under FSMA are listed in the text box.
FSMA’s Requirements Related to Food Imports
Hazard Analysis and Risk-Based Preventive
Controls (§103): Mandatory preventive controls for both
domestic and foreign food facilities.
Standards for Produce Safety (§105): Mandatory
minimum standards for fruits and vegetables (applies to
both domestic and foreign operations).
Figure 3. FDA Import Refusals, by Food Group
Laboratory Accreditation for Analyses of Food
(§202): Program to test food by accredited labs.
Foreign Supplier Verification (§301): Program for
importer verification of imported foods.
Voluntary Qualified Importer Program (§302):
Program to provide for the expedited review and
importation of foods from participating importers.
Import Certification (§303): Requirements for food
entities to provide certification concerning imported foods.
Prior Notice Requirements (§304): Requirements for
food entities to submit prior notice of imported food.
Building Capacity of Foreign Governments (§305):
Technical support to foreign governments.
Improved Enforcement Authorities (§306): Federal
inspection of registered foreign facilities.
Source: CRS from FDA import refusal data (September 2014). Data
are calendar year and cover a five-year period (2009-2013).
Accredited Third-Party Certification (§307): Program
Percentages reflect share of the total number of refusals.
of qualified third-party auditors to certify that foreign food
facilities are in compliance with U.S. standards.
Federal Food Safety Oversight
Foreign Offices (§308): Report on the selection of the
Numerous agencies share responsibility for ensuring the
foreign countries for established offices.
safety of the U.S. food supply. FDA and FSIS are the two
Smuggled Food (§309): Strategy to identify and prevent
primary federal food safety agencies: FDA is responsible
entry of smuggled food.
for regulating the safety and labeling of most foods and
beverages (excluding alcohol) and the manufacture and
distribution of shell eggs, most seafood, and drugs and
feeds for animals. FSIS is responsible for regulating the
Renée Johnson, Specialist in Agricultural Policy
safety and labeling of meat, poultry, and some egg products
IF10403
and catfish. Other USDA agencies and the National Marine
Fisheries Service at the Department of Commerce also
https://crsreports.congress.gov
Efforts to Address the Safety of FDA-Regulated Food Imports
Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to
congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress.
Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has
been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the
United States Government, are not subject to copyright protection in the United States. Any CRS Report may be
reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include
copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you
wish to copy or otherwise use copyrighted material.
https://crsreports.congress.gov | IF10403 · VERSION 3 · NEW
May 5, 2016
Efforts to Address the Safety of FDA-Regulated Food Imports
High-profile foodborne outbreaks and incidents involving
Table 1. Import Share of U.S. Food Consumption
imported foods have generated growing concerns about
1993
2003
2013
whether current federal programs sufficiently ensure the
Selected Food Groups
safety of these imports. Safety concerns have been
(percent)
associated with imported products from China, Mexico, and Total consumed food
12.8
16.0
19.4
nations in Central and South America, Southeast Asia,
Europe, and elsewhere. Some imported products that have
Red meat
7.6
9.3
7.4
raised concerns include fish and seafood, fruits and
Poultry/eggs
0.0
0.1
0.4
vegetables, and pet foods. These products fall primarily
Dairy products
1.9
3.6
1.9
under the responsibility of the Food and Drug
Administration (FDA) at the U.S. Department of Health and Fish and shellfish
54.6
82.1
96.6
Human Services and the Food Safety and Inspection
Grains
20.4
13.9
15.5
Service (FSIS) at the U.S. Department of Agriculture
(USDA).
Fruits and nuts
30.3
36.8
48.7
Vegetables
7.9
14.8
20.0
Food imports have been steadily increasing over the past
Sweeteners
16.6
16.7
25.0
decade due to globalization and consumer demand for a
wider variety of foods year-round. By volume, imports rose Spices
75.1
83.5
86.3
nearly 60% (2004 to 2014), driven in part by increased
Source: CRS from USDA data based on volume.
imports of fruits and vegetables and some processed foods
(Figure 1). Imports now account for nearly one-fifth of all
Data on FDA Refusals of Imported Food Products
foods consumed in the United States and an even larger
In recent years, FDA has issued import alerts on a range of
share of consumption of some foods, such as fish and
imported foods, including pet food ingredients, seafood,
seafood (97%) and fruits and nuts (49%), among other
and dairy products and ingredients, among other foods.
products (Table 1).
Data on FDA import refusals by violation type, provided by
FDA, indicate that adulteration accounted for more than
The sheer volume of imported foods each year further
half of all refusals during 2009-2013 (Figure 2). Refusals
complicates efforts to secure the safety of imported foods
result from violations associated with misbranding and/or
and strains an already challenged U.S. food inspection and
adulteration, among other types of violations. Most
oversight system. For foods under FDA’s jurisdiction
adulteration is attributable to pathogens and their toxins
(covering all foods except most meat and poultry products),
(such as Salmonella, Listeria, and aflatoxins), with the
more than 210,000 foreign food facilities are registered
remainder attributable to chemical adulteration (such as
with FDA and are potentially subject to inspection. Each
unregistered pesticides or other illegal additives) and other
year FDA inspects about 25% of domestic food facilities
sanitary adulteration (such as filthy or decomposed
and physically examines about 2% of all food imported
appearance or unregistered processes). Misleading or
during the year. Another 1,200 eligible foreign meat and
missing labels accounted for another 42% of FDA refusals.
poultry establishments fall under USDA’s jurisdiction.
Data on FDA import refusals by food group indicate that
Figure 1. U.S. Food Imports, by Food Group
fish and seafood, vegetables and fruits, and processed snack
foods and baked goods accounted for nearly 60% of all
import refusals during 2009-2013 (Figure 3). Most produce
refusals were due to violative residues (such as pesticides);
filth, microbial pathogens, and bacterial contamination
(mostly Salmonella); and improper process filing. Import
violations were reported to be found in products 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 other Asian nations.
Source: CRS from USDA data. Excludes some product groups.
While attention has focused on the safety of imported
foods, it remains unclear whether imported foods pose any
greater safety risk than domestically produced foods.
https://crsreports.congress.gov
link to page 1
Efforts to Address the Safety of FDA-Regulated Food Imports
Limited available data on foodborne outbreak investigations
oversee quality and grading standards for some foods but
are published by the Centers for Disease Control and
do not strictly play a food safety role. The U.S. Customs
Prevention (CDC) in its Foodborne Outbreak Online
and Border Protection at the Department of Homeland
Database (FOOD) Tool. FOOD data are a small
Security plays an important role regarding food imports as
convenience sample (i.e., not a random sample) of
part of the agency’s overall oversight role at U.S. borders.
outbreaks in the United States each year. Also, outbreaks
account for less than half of all foodborne illnesses each
The FDA Food Safety Modernization Act (FSMA, P.L.
year. CDC has noted that the origin of a food—whether
111-353) includes several provisions on food imports
domestic or imported—is often difficult to determine. The
imposing tighter controls, setting minimum entry
FOOD system does not attempt to capture this information.
requirements, requiring certification of imported foods, and
CDC has previously commented that when it looked
raising importer accountability. FSMA created several new
specifically at outbreaks that were attributed to imported
programs and requirements, including a program for
foods, it found that fish and spices were the imported foods
expedited entry and capacity building in foreign countries.
most often linked to outbreaks (which is consistent with the
Other FSMA requirements establishing preventive controls
import shares of these foods in Table 1). Nearly 45% of the
and standards for produce also apply to both imported and
imported foods causing outbreaks came from Asia.
domestically produced products. FDA has issued final
FSMA regulations, which will be phased in over the next
Figure 2. FDA Import Refusals, by Violation
few years. FSMA’s import requirements place more
responsibility on U.S. trading partners. Some claim that
FSMA requirements could influence food safety efforts
worldwide once implemented. Key import requirements
under FSMA are listed in the text box.
FSMA’s Requirements Related to Food Imports
Hazard Analysis and Risk-Based Preventive
Controls (§103): Mandatory preventive controls for both
domestic and foreign food facilities.
Standards for Produce Safety (§105): Mandatory
minimum standards for fruits and vegetables (applies to
both domestic and foreign operations).
Figure 3. FDA Import Refusals, by Food Group
Laboratory Accreditation for Analyses of Food
(§202): Program to test food by accredited labs.
Foreign Supplier Verification (§301): Program for
importer verification of imported foods.
Voluntary Qualified Importer Program (§302):
Program to provide for the expedited review and
importation of foods from participating importers.
Import Certification (§303): Requirements for food
entities to provide certification concerning imported foods.
Prior Notice Requirements (§304): Requirements for
food entities to submit prior notice of imported food.
Building Capacity of Foreign Governments (§305):
Technical support to foreign governments.
Improved Enforcement Authorities (§306): Federal
inspection of registered foreign facilities.
Source: CRS from FDA import refusal data (September 2014). Data
are calendar year and cover a five-year period (2009-2013).
Accredited Third-Party Certification (§307): Program
Percentages reflect share of the total number of refusals.
of qualified third-party auditors to certify that foreign food
facilities are in compliance with U.S. standards.
Federal Food Safety Oversight
Foreign Offices (§308): Report on the selection of the
Numerous agencies share responsibility for ensuring the
foreign countries for established offices.
safety of the U.S. food supply. FDA and FSIS are the two
Smuggled Food (§309): Strategy to identify and prevent
primary federal food safety agencies: FDA is responsible
entry of smuggled food.
for regulating the safety and labeling of most foods and
beverages (excluding alcohol) and the manufacture and
distribution of shell eggs, most seafood, and drugs and
feeds for animals. FSIS is responsible for regulating the
Renée Johnson, Specialist in Agricultural Policy
safety and labeling of meat, poultry, and some egg products
IF10403
and catfish. Other USDA agencies and the National Marine
Fisheries Service at the Department of Commerce also
https://crsreports.congress.gov
Efforts to Address the Safety of FDA-Regulated Food Imports
Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to
congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress.
Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has
been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the
United States Government, are not subject to copyright protection in the United States. Any CRS Report may be
reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include
copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you
wish to copy or otherwise use copyrighted material.
https://crsreports.congress.gov | IF10403 · VERSION 3 · NEW