Food Consumption/Nutrition/Food Safety, International Relations/Trade, F1, I18, Q17,

Buzby, Jean C.

Regmi, Anita

English

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	 2nd	Quarter	2009	•	24(2)	 CHOICES  11
AAEA
Agricultural & Applied
Economics Association
A publication of the 
Agricultural & Applied 
Economics Association
FDA Refusals of Food Imports by Exporting 
Country Group
Jean C . Buzby and Anita Regmi
JEL Classifications: F1, I18, Q17
U.S. food imports grew rapidly in recent years, and some 
of the fastest growing imports came from the developing 
countries. Brooks, Buzby, and Regmi (2009) found that 
the share of total U.S. food imports from high-income 
countries declined from 51% in 2002 to 47% in 2007. 
In general, four-fifths of the total U.S. food imports from 
high-income countries are sourced either from Canada or 
the European Union. The loss of market share for these 
countries was accompanied by a growth in U.S. import 
market share for developing countries, particularly mid-
dle-income countries, such as Mexico, Chile, and China. 
In many cases, lower-income countries may not have as 
extensive or effective food safety standards, practices, and 
regulations in place as those in the United States or in other 
more developed countries. This challenges their food safety 
systems to keep pace with the growth in their food exports. 
Buzby, Unnevehr, and Roberts (2008) analyzed U.S. 
Food  and  Drug  Administration  (FDA)  refusals  of  food 
imports between 1998 and 2004 due to violations of the 
laws FDA enforces. These laws mostly cover product adul-
teration, such as unsafe chemical residues and microbial 
contamination, and misbranding, such as inadequate label-
ing. Given the growth in food imports, particularly from 
developing countries, there is a need to closely examine 
the nature of U.S. food import growth and the correlation 
between FDA import refusals and different levels of eco-
nomic development of exporting countries. 
How Was the Study Conducted?
We analyzed FDA data on refusals of food offered for im-
portation into the United States during 1998 to 2004 by 
food industry group and by type of violation to see if there 
was a correlation between import source and FDA import 
refusals. Here, the term violation refers to products that ap-
pear to violate one or more of the laws enforced by FDA. 
Imports of most meat products fall under the jurisdiction 
of USDA’s Food Safety and Inspection Service (FSIS) and 
not FDA’s, so only a few meat products are recorded in the 
FDA import refusals data. 
In order to properly interpret the FDA data, it is im-
portant to understand that import violations do not neces-
sarily imply that a particular product posed food safety or 
other risks but rather they highlight problems associated 
with certain products, manufacturers/shippers, and coun-
tries that appear to recur in trade and where the FDA has 
focused its import alerts and monitoring efforts (see Figure 
1). FDA relies on risk-based criteria to guide its actions, in-
cluding data on products and manufacturers with a history 
of violating U.S. import regulations. Because FDA looks 
more closely where there have been problems in the past, 
there will be a higher incidence of refusals for some prod-
ucts, manufacturers/shippers, and countries. A violation 
or a refusal of a shipment does not necessarily mean that 
there was a violative product, but rather that the product 
appeared to be violative in FDA’s judgment. According to 
England (2000): Section 801(a) of the Food, Drug, and 
Cosmetic act, “gives the authority to FDA to refuse admis-
sion of any article that “appears” to be in violation” of one 
of the laws enforced by FDA. “The significance of the ap-
pearance standard under FDA law is that the Government 
is NOT required to prove an ACTUAL VIOLATION of 
law or the regulations has occurred. Rather, the FDA must 
be able to show that there exists an “appearance” of a vio-
lation to refuse admission of goods. The appearance of a 
violation may arise by the examination of physical samples, 
a field examination, review of entry documents, or based 
upon the history of prior violative shipments made from 
the same shipper.” 12  CHOICES	 2nd	Quarter	2009	•	24(2)	
The World Bank’s list of econo-
mies  (July  2006  version)  was  used 
to identify the distribution of all im-
port  violations  among  low-,  lower 
middle-,  upper  middle-,  and  high-
income countries. We consider high-
income countries to represent devel-
oped  countries  and  the  other  three 
groups to represent developing coun-
tries. We examined commodity and 
country level trade data from the U.S. 
Department of Commerce for fiscal 
years 1998–2007 to understand the 
volume and value of food trade from 
different  countries  and  to  estimate 
the number of violations per billion 
dollars of imports.
What Did We Find?
Of  the  70,366  FDA  violations  for 
food  during  1998–2004,  70,333 
identified  the  country  of  origin  for 
the food shipment. In general, there 
were  roughly  twice  as  many  viola-
tions in each of the last three years 
of the data than in each of the previ-
ous four years. Some of this growth 
may reflect the strengthening of the 
reporting system in later years. The 
distribution of FDA violations across 
the  country  groups  somewhat  mir-
rors the distribution for the value of 
total U.S. food imports across simi-
lar groups of source countries. As the 
developed country share of food im-
port value started to decrease in 2002, 
their  share  of  the  total  number  of 
FDA import violations also began to 
decline from 38% in 2002 to 29% in 
2004 (Figure 2). The share attributed 
to  low-income  countries  increased 
fairly  consistently  over  the  period, 
from 12% in 1998 to 15% in 2002, 
and 18% in 2004, while the share for 
lower  middle-income  countries  has 
generally been rising since its low in 
2000. Meanwhile the share of total 
FDA  violations  for  upper  middle-
income countries appears to be on a 
declining  trend,  perhaps  indicative 
of improving food standards, regula-
tions, and practices. 
In addition to higher growth in 
the number of import refusals dur-
ing  2002–04,  developing  countries 
also  registered  a  greater  number  of 
FDA  refusals  per  billion  dollars  of 
U.S.  food  imports  during  1998–04 
(Table 1). The estimate is highest for 
low-income countries at 605 import 
refusals per billion dollars, followed 
by lower middle-income countries at 
264 refusals per billion dollars. This 
finding helps support the need to tar-
get  capacity  building  and  technical 
assistance to less-developed countries 
that export food to the United States. 
For  example,  the  number  of  viola-
tions  due  to  package  labeling  that 
were  incomplete  or  not  in  English 
could be reduced in the future with 
greater clarity of U.S. import require-
ments and greater capacity building. 
Additionally, information sharing on 
good agricultural and manufacturing 
practices can help reduce the contam-
ination of food with filth and micro-
bial pathogens.
Total imports in billions of dollars 
and the number of import violations 
per billion dollars are also presented 
by country group for consumer-ready 
foods  (Table  1).  This  is  important 
for food safety reasons because these 
foods  include  items,  such  as  fruit, 
vegetables,  meat,  seafood,  and  pro-
cessed  foods,  that  may  not  have  a 
Figure 1. Import Alerts and Detention without Physical Examination
Import alerts were developed by the FDA to communicate guidance for import coverage to FDA 
personnel in field offices, as well as to identify and disseminate import information on problems and 
violative trends. Import alerts facilitate uniform and effective import coverage. They identify problem 
products and/or manufacturers/shippers, such as those that have met the criteria for detention 
without	physical	examination.	These	alerts	are	posted	on	FDA’s	Import	Alert	Retrieval	System	(FIARS)	
on	their	website	(www.fda.gov/ora/fiars/ora_import_alerts.html).
Example: Import Alert 21-03 calls for increased surveillance of all dried apricots 
and apricot paste from all countries because of historical problems with insect 
and rodent filth.
Detention without physical examination (DWPE) is a notice in an import alert 
that means that subsequent shipments for a specific product and manufacturer/shipper will be refused 
entry into U.S. commerce unless evidence is presented, such as test results, to FDA proving the item 
meets	safety	requirements	(FDA,	CFSAN,	Feb./March	2002).	
Example: Import Alert 16-81 calls for detention without physical examination 
of specific seafood products due to Salmonella contamination from specific 
manufacturers/shippers in several countries, including, frozen rock lobster tails 
from a specific firm in Brazil and frozen shrimp from a specific firm in Vietnam. 
Figure 2. Share of Total FDA Import Violations by Country Groups	 2nd	Quarter	2009	•	24(2)	 CHOICES  13
further cooking step to destroy any 
pathogens  should  they  be  present 
in the food. Some might argue that 
consumer-ready foods should require 
a higher level of care than foods that 
will be cooked or otherwise treated in 
additional preparation steps. 
Buzby,  Unnevehr,  and  Roberts 
(2008) identified the three food in-
dustry  groups  with  the  most  viola-
tions:  vegetables  (20.6%  of  total 
violations),  fishery  and  seafood 
(20.1%), and fruits (11.7%). Brooks 
et al. (2009) found that these were 
the  same  food  groups  which  regis-
tered the fastest import growth rates. 
Therefore, this study also looks more 
closely at the import refusals in these 
three food industry groups by coun-
try grouping.
Since  middle-income  countries, 
led  by  Mexico,  China,  India,  and 
other countries in Central and South 
America  are  the  biggest  sources  of 
vegetable  and  vegetable  food  prod-
uct imports into the United States, 
it is reasonable to find that middle-
income countries also account for a 
large share of total FDA violations on 
imports of these products (Figure 3). 
Although the shares of product viola-
tions have fluctuated among the four 
income groups over time, there has 
been  little  change  between  the  dis-
tribution of shares at 1998 and 2004 
levels.  Upper  and  lower  middle-in-
come countries have jointly account-
ed for about 72–73% of total FDA 
violations in both 1998 and 2004. 
Of the 14,463 violations cited by 
FDA in refusals of vegetable and veg-
etable product imports during 1998–
04, the top three violations were for 
pesticide  residues  (27%),  failure  to 
file  information  on  its  scheduled 
process  of  a  low-acid  canned  food 
or an acidified food (23%), and filth 
(14%). Vegetable and vegetable prod-
uct imports had relatively few viola-
tions  for  microbial  pathogens  (for 
example,  139  Salmonella  violations; 
37 Shigella violations; 1 Listeria vio-
lation). Pesticide residue levels are set 
with very conservative thresholds and 
failure to file a scheduled process is a 
procedural violation. Most of the vio-
lations for vegetables do not suggest 
immediate food safety risks.
Rising imports of fish and seafood 
products  from  developing  countries 
and  declining  market  shares  of  de-
veloped  countries  are  reflected  in 
the shares of FDA import refusals by 
country group (Figure 4). The most 
notable change is the increased share 
of  FDA  fishery  and  seafood  viola-
tions  during  1998–04  for  low-in-
come countries. In 1998, low-income 
countries accounted for 17% of these 
violations, compared to over 30% in 
2004. This increased violation share 
is  probably  due  to  both  increased 
imports from these countries and be-
cause FDA has issued import alerts 
concerning  fish  and  seafood  prod-
ucts from certain countries based on 
past problems. Of the 14,107 viola-
tions in the FDA fishery and seafood 
product refusals during 1998–04, the 
top three violations were filth (31%), 
Salmonella (21%), and manufacturer 
failure to file requisite information on 
low-acid canned food or on acidified 
food (8%).  
When looking at fruit and fruit 
product violations, the share attrib-
uted to the different income groups 
changed  over  time.  Most  notably, 
the  share  attributed  to  low-income 
groups more than doubled from 6% 
in  1998  to  14%  in  2004,  despite 
some fluctuation during this time pe-
Table 1. FDA Import Violations and U .S . Food Import by Country Grouping, 
1998–2004
Imports Violations/billion$
Country grouping
Total viola-
tions1
Consumer-
ready Total
Consumer-
ready 
imports
Total 
imports
Number Billion US$ Number/Billion$
Low-income 10,693 11 18 1,001 605
Lower middle-income 20,534 54 78 379 264
Upper middle-income 17,030 63 73 272 234
High-income 22,087 135 165 163 134
Source:	FDA	import	violations	are	ERS	calculations	using	FDA	Import	Refusal	Reports,	1998–2004. 
Import figures are ERS calculations using data  from U.S. Department of Commerce, Census Bureau. 
122 violations for Anguilla, British Virgin Islands, Cook Islands, and Guadeloupe were omitted.
Figure 3. Vegetable and Vegetable Products FDA Violations by Country Groups14  CHOICES	 2nd	Quarter	2009	•	24(2)	
riod (Figure 5). Also, the share from 
lower middle-income countries grew 
from its low in 1999 while the share 
from upper middle-income countries 
shrank.  This  switch  likely  reflects 
increased imports of these products 
from low-income and lower middle-
income  countries,  particularly  fresh 
products  from  countries  in  Cen-
tral and South America as noted in 
Brooks, Buzby, and Regmi (2009).
Of the 8,263 violations recorded 
for  fruit  and  fruit  product  refusals 
during 1998–04, the top three viola-
tions were for filth (23.7%), manu-
facturer  failure  to  file  information 
on  its  scheduled  process  of  a  low-
acid canned food or an acidified food 
(9%), and unsafe color (8%). The re-
maining violations were spread over a 
wide variety of reasons, such as inad-
equate labeling, unsafe pesticide resi-
dues,  and  microbial  pathogens.  For 
example, there were 131 Salmonella 
violations,  270  Listeria  violations, 
and 11 Shigella violations.  
Summary
A FDA violation means that the prod-
uct appeared to violate one or more of 
the laws enforced by FDA, including 
adulterated or misbranded products. 
It does not necessarily imply an actual 
food safety or other risk was associ-
ated with the product. Nevertheless, 
the import refusals data are informa-
tive as they highlight food safety and 
other problems with certain products, 
shippers, and countries that appear to 
recur in trade and identify areas where 
FDA has focused its import alerts and 
monitoring efforts. 
There has been a noted increase 
in the share of FDA refusals of food 
imports from low-income countries. 
The products with the highest share of 
violations in imports refused entry by 
FDA are also those for which imports 
are rising most rapidly (that is, vege-
tables, fish/seafood, and fruit). There-
fore, we closely examined the sources 
for these imports and found that the 
growth in the number of FDA viola-
tions among country groups is most 
evident for low-income countries for 
fish  and  seafood,  and  for  fruit  and 
fruit products. In addition to higher 
growth in the share of import refus-
als  during  1998–2004,  low-income 
countries  also  registered  the  most 
FDA  refusals  per  billion  dollars  of 
U.S. food imports during this period. 
This is important because it provides 
information to target capacity build-
ing and technical assistance to low-
income  countries  that  export  food 
to the United States, particularly for 
fish/seafood and fruit exports. 
For More Information
Buzby, J.C., Unnevehr, L., and Rob-
erts,  D.  (2008).  Food  safety  and 
imported food: An analysis of FDA 
food-related import refusal reports, 
EIB  39,  Washington,  DC:  U.S. 
Department of Agriculture, Eco-
nomic Research Service.
Brooks N., Buzby, J.C., and Regmi, 
A.  (2009).  Globalization  and 
evolving  preferences  drive  U.S. 
food  import  growth.  Journal  of 
Food Distribution Research, 40(1), 
39–46.
England,  B.L.  (2000,  October  27). 
Import  operations,  policies,  and 
procedures. Presented by the Regu-
latory  Counsel  to  the  Associate 
Commissioner  for  Regulatory 
Affairs, U.S. Food and Drug Ad-
ministration.
Figure 5. Fruit and Fruit Products FDA Violations by Country Groups
Figure 4. Fishery and Seafood FDA Violations by Country Groups	 2nd	Quarter	2009	•	24(2)	 CHOICES  15
The Word Bank. (2006). World De-
velopment  Indicators.  Available 
online: http://devdata.worldbank.
org/wdi2006/contents/index2.
htm
U.S. Department of Commerce, Bu-
reau of the Census, Foreign Ag-
ricultural  Service.  (2008).  U.S. 
trade  internet  system.  Available 
online:  http://www.fas.usda.gov/
ustrade/.
U.S.  Food  and  Drug  Administra-
tion (FDA). (2009). Import alert 
retrieval system (FIARS), Available 
online:  www.fda.gov/ora/fiars/
ora_import_alerts.html.
U.S.  Food  and  Drug  Administra-
tion  (FDA).  (2007,  April  1  re-
vision).  Code  of  federal  regula-
tions, Title 21, Volume 6, CITE: 
21CFR582.20. 
Jean  C.  Buzby  (jbuzby@ers.usda.
gov) and Anita Regmi (aregmi@ers.
usda.gov)  are  both  economists  with 
the  U.S.  Department  of  Agriculture’s 
Economic  Research  Service,  Washing-
ton, D.C.

FDA Refusals of Food Imports by Exporting Country Group

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