Food and Agricultural Imports from China

Food and Agricultural Imports from China
Updated September 26, 2008
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science, and Industry Division

Food and Agricultural Imports from China
China is now the third largest source of U.S. agricultural and seafood imports.
A series of incidents have raised public concerns about the safety of these products.
In September 2008, U.S. authorities said they broadened their testing of milk-derived
products from China, following reports that melamine-contaminated baby formula
has sickened tens of thousands of Chinese children. They also announced a recall of
some coffee products that may contain melamine.
Early in 2007, evidence emerged that adulterated pet food ingredients from
China had caused the deaths of a large number of dogs and cats. In late June 2007,
the U.S. Food and Drug Administration (FDA) announced that it was detaining all
imports of farm-raised seafood from China until shippers could confirm they are free
of unapproved drug residues.
U.S. imports of Chinese agricultural and seafood products increased roughly
fourfold, from 433,000 metric tons (MT) and $1 billion in 1997 to 2.1 million MT
and $4.9 billion in 2007. However, the United States exported a much larger volume
of these products to China in 2007: 14.7 million MT, valued at $8.8 billion.
Two federal agencies — FDA and the U.S. Department of Agriculture’s
(USDA’s) Food Safety and Inspection Service (FSIS) — are primarily responsible
for the government’s food regulatory system, although a number of other federal,
state, and local agencies also have important roles. For imports, FSIS (which
regulates the safety of most meat and poultry) relies on a very different regulatory
system than FDA (which regulates the safety of all other foods). Although all
imported food products must meet the same safety standards as domestically
produced foods, international trade rules permit a foreign country to apply its own,
differing, regulatory authorities and institutional systems in meeting such standards,
under an internationally recognized concept known as “equivalence.”
China officials assert that they have been moving aggressively to improve their
food safety system and to close unsafe plants. China in late 2007 concluded a
memorandum of agreement with the United States aimed at improving the safety of
traded food and feed products. Nonetheless, some Members of Congress continue
to express sharp criticism of both China’s food safety record and U.S. efforts to
insure import safety. In the 110th Congress, committees on both sides of Capitol Hill
held hearings on food safety concerns generally and on the China situation.
Numerous bills were introduced focusing on imported food safety or containing such
provisions, which would apply equally to Chinese imports. These bills include H.R.

2997, S. 1776, H.R. 1148/S. 654, H.R. 2108/S. 1274, H.R. 3100, H.R. 3610, H.R.

3624, H.R. 3937, H.R. 3967, and S. 2418.

A provision in the FDA Amendments Act of 2007 (P.L. 110-85), passed in
September 2007, requires an annual report to Congress with detailed data on
FDA-regulated food imports. Also in 2007, Congress cleared a consolidated
appropriation act for FY2008 which includes a provision blocking an FSIS rule to
allow certain poultry products to be imported from China.

In troduction ......................................................1
Milk Product Safety Concerns........................................2
World Reaction...............................................3
U.S. Implications..............................................4
U.S.-China Trade Trends............................................5
U.S. Import Safeguards.............................................7
Overview ....................................................7
FSIS ........................................................8
FDA ........................................................8
FDA Import Refusals..............................................10
Overview and Limitations of Analysis............................10
Types of Chinese Imports Refused...............................11
Chinese Food Safety Challenges.....................................12
U.S. Efforts to Improve Import Compliance........................14
Food Safety and Import Plans...............................14
Bilateral Memorandum of Agreement.........................15
Other Bilateral Efforts.....................................16
Detention of Chinese Seafood...............................16
Chinese Efforts to Address Food Safety...........................17
Congressional Consideration........................................19
List of Tables
Table 1. Imports of Chinese Dairy Ingredients and Products................4
Table 2. Selected Agricultural and Seafood Imports from China, 2007........6
Table 3. Selected Agricultural and Seafood Exports to China, 2007..........7

Food and Agricultural Imports from China
Food and agricultural imports have increased significantly in recent years,
causing some in Congress to question whether the U.S. food safety system can keep1
pace. A series of recent incidents have raised safety concerns about many of these
foods, medicines, and other products, particularly from China, the third-largest
source of U.S. agricultural and seafood imports.
In September 2008, for example, U.S. authorities said they were more closely
monitoring imports of dairy products and dairy-based ingredients from China,
following reports that four infants died there and tens of thousands of other young
children have been sickened by consumption of milk products, primarily infant
formula, contaminated with the chemical melamine. A reported 13,000 infants were
hospitalized. A number of countries have banned various dairy-related imports from
China and/or pulled Chinese products from store shelves.
In early 2007, evidence had emerged that adulterated pet food ingredients from
China had caused the deaths of many dogs and cats. A subsequent survey counted2
347 cases (235 cats and 112 dogs) of pets dying from contaminated pet food. Some
ingredients also were fed to U.S. food animals, although federal officials claimed that
humans were not at risk.
In late June 2007, the U.S. Food and Drug Administration (FDA) announced
that it was detaining all imports of farm-raised seafood from China (specifically,
shrimp, catfish, basa, dace, and eel) until the shippers of these products could
confirm that they are free of unapproved drug residues. Chinese importers remained
subject to these conditions in 2008.
While strongly defending its record, the Chinese government also has
announced a variety of steps to improve the safety of its food and drug exports,
including revisions in its regulations, new inspections, and the closure of problem
plants. It also signed, in late 2007, a memorandum of agreement with the U.S.
government pledging expanded cooperation to ensure the safety of many of its food
and feed products. The FDA is moving to station some officials in China to provide
closer oversight. At the same time, China has blocked the importation of some types
of U.S. food products, ostensibly out of food safety concerns.

1 For an overview of food import safety issues, see CRS Report RL34198, U.S. Food and
Agricultural Imports: Safeguards and Selected Issues, by Geoffrey S. Becker.
2 Michigan State University, “MSU survey determines that more than 300 pets may have
died from contaminated pet food; culprit may be lethal combination of contaminants,” news
release, November 29, 2007, at [].

These and other developments greatly heightened public and congressional
scrutiny not only of China’s own food safety regime, but also of the adequacy of U.S.
import safeguards. During the 110th Congress, a number of congressional
committees held hearings on, or launched investigations of, food imports from China
and elsewhere. Committees reviewed U.S. laws and regulations designed to ensure
import safety. Many bills were introduced to clarify and expand federal authorities
affecting both imported and domestic foods, and/or to reorganize agency
This CRS report first provides information on the most recent Chinese-related
food safety concern, the use of melamine in dairy ingredients. Following this section,
the report provides data on U.S.-China trends in agricultural trade, examines U.S.
programs to monitor the safety of imports, and reports on other recent Chinese food
safety developments. It concludes with a brief discussion of the congressional role.
Milk Product Safety Concerns
In a food safety crisis that was continuing to unfold in late September 2008,
approximately 54,000 or more young children have been sickened in China,
reportedly suffering from the consumption of milk powder contaminated with3
melamine. A reported 13,000 of them were hospitalized, and four infants died.
According to various press reports, as early as mid-July 2008, one provincial
government had told Chinese health officials about an unusually high number of
kidney stones in babies who had all consumed the same milk product. However,
Chinese authorities did not hold a news conference to announce a nationwide recall
of 700 tons of milk powder until September 11, 2008.
Melamine is an industrial chemical used in the manufacture of plastic, including
kitchen products, countertops, and floor tiles. When ingested, it can crystallize and
cause kidney stones and, ultimately, kidney damage and kidney failure. Pet foods
made with melamine-tainted wheat gluten imported from China into the United
States were linked to the hundreds of pet deaths in 2006 and 2007.
In the recent dairy product crisis, the focus initially was on milk powder
manufactured by the Chinese company Sanlu, of which the New Zealand dairy giant
Fonterra owns a 43% share. Sanlu reportedly obtains its milk from middlemen who
collect it from local farmers. Investigators believe that these middlemen deliberately
were adding melamine to boost product protein content readings of milk that had
been watered down to increase its volume. Chinese officials said the practice could
have been under way for years. Smaller traces of melamine also reportedly were
found in the milk powder of 21 other Chinese companies.

3 Unless noted otherwise, this section was prepared from numerous press accounts published
throughout September 2008, including by Reuters, The Economist, The Times of London,
Food Chemical News, The New Zealand Herald, and the Associated Press.

World Reaction
Concerns about these problems quickly spread to other countries throughout the
world. Chinese dairy products were recalled or pulled from shelves throughout Asia
and in some African countries. As of late September 2008, at least 12 countries had
banned Chinese dairy imports. Health authorities in these and many other countries
are testing various baked goods and candies most often sold at Asian specialty stores,
if they contain dairy ingredients.
The New Zealand Food Safety Authority said it had found unacceptably high
levels of melamine in Chinese-made White Rabbit Creamy Candies and warned
people not to consume them.4 The Canadian Food Inspection Agency issued a recall
of, and warned consumers not to consume, the Mister Brown brand of instant coffee
products (as did the United States; see below). Health authorities in a number of
countries also were sampling and testing various dairy protein product imports from
China, including casein, caseinates, milk powders, whey powder, and lactose powder.
Noting that other food products such as biscuits and chocolate, which could be
made from contaminated milk powder, may have reached the European Union (EU),
the European Commission asked the European Food Safety Agency (EFSA) to
provide “urgent scientific advice” on the matter. EFSA issued a statement on
September 25, 2008 saying, in part:
Estimated exposure does not raise concerns for the health of adults in Europe
should they consume chocolates and biscuits containing contaminated milk
powder. Children with a mean consumption of biscuits, milk toffee and
chocolate made with such milk powder would also not exceed the TDI [tolerable
daily intake, which is 0.5 mg/kg body weight]. However, in worst case scenarios
with the highest level of contamination, children with high daily consumption of
milk toffee, chocolate or biscuits containing high levels of milk powder would
exceed the TDI. Children who consume both such biscuits and chocolate could
potentially exceed the TDI by more than threefold. However, EFSA noted that
it is presently unknown whether such high level exposure scenarios may occur5
in Europe.
The EU also reportedly has banned imports of baby foods containing Chinese
milk power and required testing of all products containing more than 15% milk

4 New Zealand Food Safety Agency, September 24, 2008, statement.
5 “Statement of EFSA on risks for public health due to the presences of melamine in infant
milk and other milk products in China,” accessed on September 25, 2008, at
[]. In
the absence of actual data for milk powder, EFSA used the highest value of melamine
(approximately 2,500 mg/kg) reported in Chinese infant formula as a basis for worst case

U.S. Implications
In a health information advisory issued on September 12, 2008, the U.S. FDA
stated that there is no known threat of contamination in infant formulas “that have
met the requirements to sell such products in the United States.” FDA said that it had
been reassured by companies that manufacture infant formula for the U.S. market that
they are not importing formula or sourcing milk-based materials from China. The
FDA said it also was investigating Asian markets throughout the United States to see
whether any were stocking Chinese-made infant formula.
Nonetheless, in a September 26, 2008, update, the FDA said that the King Car
Food Industrial Co. was recalling six types of Mr. Brown instant coffee and one Mr.
Brown Milk Tea due to possible contamination with melamine. FDA also warned
consumers not to consume these products or White Rabbit Creamy Candy, adding
that it was not aware of any U.S. health problems related to these products.
The United States does import from China some milk-based products, primarily
as ingredients that are in turn used in the manufacture of other foods. In its
September 23, 2008, update of its advisory, the FDA said it “has broadened its
domestic and import sampling and testing of milk-derived ingredients and finished
food products containing milk, such as candies, desserts, and beverages that could
contain these ingredients from Chinese sources. Milk-derived ingredients include
whole milk powder, non-fat milk powder, whey powder, lactose powder, and
casein.”6 Table 1, below, shows the volume of recent U.S. imports of Chinese dairy
ingredients and products.
Table 1. Imports of Chinese Dairy Ingredients and Products
(metric tons)
Item2007 (January-December)2008 (January-July)
Casein 1,945.6 847.5
Caseinates & derivatives339.055.0
Other natural milk proteins194.4100.0
Cheese (proc.; not fresh)14.30.0
Source: Data from USDA, Foreign Agricultural Service (FAS), U.S. Trade Imports - HS 6-Digit
As Table 1 shows, casein is the largest type of dairy-related import from China.
As context, China accounted for no more than 2% of all U.S. casein imports from
January 2007 through July 2008. According to a U.S. government study, 68% of all

6 “FDA Updates Health Information Advisory on Melamine Contamination,” September 23,
2008, FDA statement. As of September 25, 2008, testing had not produced any positive
results for melamine, according to FDA.

casein purchases in 2002 were used here for nondairy food products, primarily
imitation cheese and coffee creamers. Fourteen percent were used in specialty
nutrition products, 9% in other dairy foods, and 7% in processed cheese products.
Caseinates are mainly (93%) used in specialty nutrition products such as ready-to-
drink beverages, drink powders, power bars and other forms of sports and medical
nutrition applications.7
U.S.-China Trade Trends
U.S. imports of agricultural and seafood products from all countries increased
from 35.9 million metric tons (MMT) in 1997 to 48.7 MMT in 2007, or by 36%. The
increase by value was 95%, from $43.8 billion in 1997 to $85.4 billion in 2007.
Among the product categories that more than doubled in volume during the period
were live animals, wine/beer, fruit/vegetable juices, wheat, coffee, snack foods, and8
various seafood products.
Not all agricultural imports are used for human food; some products are
ingredients in pet food and animal feed, in manufactured goods (e.g., rubber), and in
the nursery plant trade. Nonetheless, many consumers are obtaining a growing
portion of their diets from overseas. In 2005, nearly 15% of the overall volume of
U.S. food consumption was imported, compared with 11%-12% in 1995. The
proportions (volume) for some food product categories were much higher: in 2005
as much as 84% of all U.S. fish and shellfish was imported (55% in 1995); 43% of
all noncitrus fresh fruits (34% in 1995); 37% of all processed fruits (20% in 1995);9
and 54% of all tree nuts (40% in 1995).
U.S. imports of Chinese agricultural and seafood products have increased far
more rapidly, from 433,000 metric tons (MT) and $1 billion in 1997 to 2.1 million
MT and $4.9 billion in 2007. China was the third leading foreign supplier of these
products to the United States in 2007, after Canada and Mexico.
Table 2, below, shows the major types of food and agricultural imports from
China in 2007. Seafood products, including shrimp, other shellfish (mollusks), and
salmon, were the leading food-related (i.e., agricultural and seafood) imports. Fruits,
fruit juices, vegetables, tree nuts, teas, and spices also were high on the list.
The broader categories in Table 2 mask some specific products that the United
States imports in large quantities from China. For example, a 2007 report by Food
and Water Watch, a consumer advocacy organization, noted that China became the

7 U.S. International Trade Commission, Conditions of Competition for Milk Protein
Products in the U.S. Market (Investigation No. 332 — 453), May 2004.
8 U.S. Department of Agriculture (USDA), Foreign Agricultural Service (FAS), U.S. Trade
Internet System, BICO (Bulk, Intermediate, and Consumer-Oriented) data.
9 USDA, Economic Research Service (ERS), unpublished data, obtained May 11, 2007.
Other data, including that provided by FDA, indicate that the current percentage for seafood
is somewhat lower than 84%.

leading exporter of seafood to the United States in 2004. Aquaculture facilitated this
export growth, particularly for shrimp and tilapia. Catfish, eel, and crab imports also
rose significantly.10
Table 2. Selected Agricultural and Seafood Imports from China, 2007
ImportValue ($1,000)(metric tons unless specified)
Other fish & products (not listed below)$1,228,226359,215
Fruit juices (kiloliters)433,3871,610,250
Fruit, processed286,207323,767
Misc. horticultural products283,667118,194
Shrimp & prawns236,35448,610
Mollusks 207,262 55,184
Other crustaceans186,58023,217
Feed, ingredients & fodders167,94263,554
Vegetables, prepared or preserved165,699146,971
Misc. industrial use 154,10611,876
Poultry, misc.135,72514,122
Sugar & related products125,87354,470
Salmon 111,322 27,119
Fresh vegetables, excluding potatoes103,90992,795
Vegetables, dried/dehydrated103,86270,711
Misc. meat products97,32218,230
Edible tree nuts86,58211,051
Grains and feed, misc.84,23950,104
Tea, excluding herbal79,54624,021
Vegetables, frozen72,41793,545
Misc. hair, industrial use71,34218,678
Other oilseed prods., nonagric.68,09125,965
Spices 64,470 45,092
Fruit, dried56,51913,079
Misc. sugar and tropical49,71116,236
Source: USDA, FAS, FAS Import Commodity Aggregations. Not all products listed.
The United States exports much more in food and agricultural products to China
than China exports to the United States. In 2007, U.S. food, agricultural, and seafood
exports to China totaled 14.7 MMT and were valued at $8.8 billion. Table 3, below,

10 Import Alert: Government Fails Consumers, Falls Short on Seafood Inspections, Food and
Water Watch, May 2007.

shows some of the major types of these U.S. exports. Many of these exports (e.g.,
much of the seafood) may be sent to China as lower-value products, processed there,
and returned to be consumed in the United States.
Table 3. Selected Agricultural and Seafood Exports to China, 2007
ImportValue ($1,000)(metric tons unless specified)
Soybeans, incl. oil & meal$4,117,40511,771,605
Cotton 1,461,216 1,062,446
Hides and skins (number)826,9421,276,317
Intermediate products, misc.454,439465,136
Poultry meat347,528324,711
Seafood, misc.341,442191,914
Salmon 158,000 56,864
Dairy products153,59790,759
Red meats142,784101,500
Consumer oriented, misc.114,29116,502
Fruits & vegetables, processed 101,589102,522
T obacco 65,955 9,521
Tree nuts53,83812,015
Feeds and fodders51,87580,477
Fresh fruit38,79339,170
Planting seeds32,28911,678
Other bulk commodities27,6006,149
Snack foods22,9299,677
Roe/urchin/fish eggs16,0724,869
Source: USDA, FAS, BICO data. Not all products listed.
U.S. Import Safeguards
Although all food products imported into the United States must meet the same
safety standards as domestically produced foods, international trade rules permit a
foreign country to apply its own differing, regulatory authorities and institutional
systems in meeting such standards, under an internationally recognized concept
known as “equivalence.”11

11 This concept is embodied in Article 4 of the Agreement on the Application of Sanitary

Two federal agencies — the U.S. Department of Agriculture’s (USDA’s) Food
Safety and Inspection Service (FSIS) and FDA, within the U.S. Department of Health
and Human Services — are primarily responsible for the government’s food
regulatory system, although a number of other federal, state, and local agencies also
have important roles. For imports, FSIS relies on a very different regulatory system
than FDA, including a different approach to addressing equivalence, as described in
the following sections.
Under Section 20 of the Federal Meat Inspection Act (FMIA) as amended (21
U.S.C. 601 et seq.) and Section 466 of the Poultry Products Inspection Act (PPIA)
as amended (21 U.S.C. 451 et seq.), FSIS is responsible for determining the
equivalence of other countries’ meat and poultry safeguards.12 A foreign plant cannot
ship products to the United States unless FSIS has certified that its country has a
program that provides a level of protection that is at least equivalent to the U.S.
system.13 In addition, FSIS operates a reinspection program at U.S. border entry
points. Generally, agency inspectors review all import records, assisted by a
computerized statistical sampling program, the Automated Import Inspection System
(AIIS), that enables targeting of some shipments for actual inspection — examining
their physical condition, labeling, and documentation. China is not yet certified to
ship FSIS-regulated meat and poultry products (i.e., the major commercial species)
to the United States.
Meat and poultry imports from other countries, however, have increased, from
nearly 2.3 billion pounds presented for inspection in FY1996 to approximately 4
billion pounds annually now. FSIS has estimated that it physically examined
approximately 20% of all such imports in FY1996 compared with approximately

10% in more recent years (after implementation of the AIIS in the early 2000s).

About 4% of imports now undergo microbiological testing, according to USDA.
Under Section 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended (21 U.S.C. 301 et seq.), FDA can refuse entry to any food import if it
“appears,” based on a physical examination or otherwise, to be adulterated,

11 (...continued)
and Phytosanitary Measures (the SPS Agreement), which entered into force January 1, 1995,
for member nations of the World Trade Organization (WTO). For a more detailed
explanation, see CRS Report RL33472, Sanitary and Phytosanitary (SPS) Concerns in
Agricultural Trade, by Geoffrey S. Becker.
12 FSIS coverage is of the major commercial red meat and poultry species and their products,
while FDA has jurisdiction over any meat and poultry not inspected by FSIS.
13 Eligible establishments from 33 countries (as of 2008) can be accessed at [http://
www. f s e x . a s p ] .

misbranded, or in violation of the law.14 In exercising its oversight, the agency 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. Import information is entered into FDA’s database, the Operational and
Administrative System for Import Support (OASIS). This system helps inspectors
determine a shipment’s relative risk and whether it needs closer scrutiny (i.e., actual
examination and/or testing). FDA inspectors work closely with Customs and Border
Protection officials from the Department of Homeland Security on these tasks.15
The volume of FDA-regulated food imports has tripled in one decade. The
agency received an estimated 8.2 million imported food lines (shipments) in FY2007,
compared with fewer than 2.8 million shipments in FY1997. Approximately 1% of
these shipments were physically examined in FY2007, compared with 1.7% in
FY1996. A food line is a single shipment, regardless of size — whether a single
carton or a large carlot — making it difficult if not impossible to determine the share
of the total volume of imports that is actually being examined.
FDA’s ability to operate within other countries appears to be more limited than
that of FSIS. FDA can, and does, periodically visit foreign facilities to inspect their
operations, but usually in response to a concern and only with the permission of the
foreign government. Furthermore, agency officials acknowledged in 2007 that FDA
has lacked the staff and funding to increase its presence overseas, regardless of
whether it might have the legal authority to do so. FDA’s budget for food activities
(domestic and imported) was $457.1 million in FY2007. FDA’s food safety staff
(FY2007) numbered approximately 1,900 in field offices throughout the United
States, plus more than 800 in its headquarters offices near Washington, D.C.
FDA might theoretically have the authority to require equivalency standards for
Chinese imports, but the agency’s situation is significantly more complex than that
of FSIS (which regulates fewer types of food products), according to David Acheson,
the FDA’s Assistant Commissioner for Food Protection.16 The Government

14 21 U.S.C. § 381(a); see also the online video CRS Multimedia MM70102, Food
Importation: Border Inspection, Detention, and Trade Issues, by Vanessa K. Burrows and
Jeanne J. Grimmett.
15 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002
(P.L. 107-188) expanded the prior notification requirements for FDA-regulated imported
foods. It also now requires any imported or domestic facility that manufactures, processes,
packs, or holds food for U.S. consumption to register with the FDA; farms and retail
establishments are among those exempted. Further, the act requires records sufficient to
identify the immediate supplier as well as the subsequent recipient of the product.
16 Comments at a May 9, 2007, hearing before the House Agriculture Committee. Source:
“Officials defend federal response to melamine contamination,” Food Chemical News, May
14, 2007. In a July 11, 2007 conference call, Dr. Acheson reportedly reiterated his concern
about the complexity of trying to seek food safety equivalency agreements with the
approximately 150 countries that ship products to the United States (Food Chemical News,
July 13, 2007).

Accountability Office (GAO) in 1998, on the other hand, asserted that FDA lacks the
statutory authority to mandate equivalency.17
FDA Import Refusals
Overview and Limitations of Analysis
Using the OASIS data, the FDA compiles a monthly “Import Refusal Report”
for food shipments that it rejects. Such products have to be either re-exported or
destroyed by the importer. The agency posts these monthly refusal reports on its
website, but only for the most recent 12 months (i.e., only one year’s worth of
refusals).18 The refusals for each month can be searched by country or by product
category, but not by both at the same time. Data for only 12 months, from May 2006
through April 2007, appeared on the website as of May 2007, when CRS last
tabulated it, and the months were not aggregated by FDA into annual figures.19
For each line (recorded shipment), the system provides the name of the source
company and the reason for refusal. As noted earlier, the size of each shipment in
the OASIS database varies. Therefore, it is not possible to calculate the volumes of
products being rejected, either as an absolute quantity or as a proportion of total
imports. Also, the types or categories of imports do not necessarily correspond to the
categories reported through the FAS trade databases (see Tables 1 and 2, above).
Mindful of these caveats, CRS prepared a tabulation of the refusals, focusing on
nearly 40 categories of FDA-regulated food and food-related products.20 For the one-
year period examined (FY2007), FDA logged a total of nearly 8,500 refusals,
representing approximately one-tenth of one percent of the 8.2 million lines entered
into OASIS during the period. Of these, more than 700 separate shipments were
from China. Two other countries had more shipments refused: Mexico and India,
each with approximately 1,150.
It is important to note that a higher relative number does not necessarily indicate
that one country’s products are less safe, or its food safety system less rigorous, than
another country’s. The country simply might be a more important source of U.S.
agricultural and/or seafood imports. On the other hand, Canada, which imports much
more to the United States than any other country, had far fewer refusals than either
China or Mexico, the second most important U.S. importer in dollar value. India had

17 GAO Report RCED-98-103, Food Safety: Federal Efforts to Ensure the Safety of
Imported Foods Are Inconsistent and Unreliable. April 1998. GAO also had concluded that
border inspections alone were ineffective.
18 Website accessed September 25, 2008, at [
19 CRS did not examine FSIS import refusals for this report. China currently is not certified
by FSIS to export FSIS-regulated meat or poultry products to the United States.
20 Also listed in the OASIS refusal reports, but not examined here, are other FDA-regulated
products, e.g., human and animal drugs, medical devices, and vitamins.

the second highest number of refusals, even though it is not among the top 10
exporters of food, agricultural, and seafood products to the United States.21
Types of Chinese Imports Refused
Of the more than 700 refused shipments from China, more than 300 were
seafood products, and approximately one-third of these products were eel. The most
frequently cited reason for rejecting the eel shipments was a concern about
adulteration by unsafe levels of veterinary drug residues. Catfish products also were
often refused, usually because of concerns about veterinary drug residues. A wide
variety of other types of finfish, from tilapia fillets to cod and salmon products, was
refused for numerous apparent concerns, including veterinary drug residues, filthy
appearance, and Salmonella contamination. More than three dozen separate shrimp
shipments were refused because of filthy appearance, the presence of nitrofuran (a
banned antibiotic), or Salmonella. Other examples of refused seafoods were scallops,
crawfish, and squid.
FDA also refused more than 200 shipments of various fruits and vegetables
from China, including processed products. Approximately one-fourth of these
shipments were of mushrooms, often in dried form; these were most frequently
rejected for filthy appearance. Other reasons for refusing fruit and vegetable product
shipments ranged from concerns about the presence of violative levels of pesticides
or other unacceptable ingredients, including unsafe color additives, to the lack of
proper documentation and/or labeling.
Seafood products and fruit and vegetable products together constituted the
majority of refused shipments from China. Examples of other types of food products
that were refused, although in fewer numbers, were certain candies, bean curd and
bean paste, teas, and various nuts and spices.
Chinese officials have strongly defended their safety record. One official
asserted at a May 31, 2007, news conference that U.S. inspectors had approved “99
percent” of all Chinese food and medical shipments over the last three years and that
recent reports of rejected Chinese shipments had been sensationalized. He further
argued that most of those that had been rejected were unauthorized shipments that
had skirted Chinese controls.22 Other Chinese officials declared in 2007 that U.S.
importing companies need to look beyond their emphasis on low prices and
communicate more clearly what their standards are.23 In September 2007, a Chinese
official asserted that problems with Chinese exports have been due either to improper
information on U.S. standards from U.S. importers, or to the failure of the United

21 Nonetheless, India’s exports to the United States were valued at a still substantial level
of more than $1.4 billion in FY2007.
22 Li Yuanping, director general of the Chinese Import and Export Food Safety Bureau, as
quoted in various news reports including “China Says Food Export Inspections Are
Effective,” Washington Post, June 1, 2007. Also see “China Confronts Crisis Over Food
Safety,” Wall Street Journal, May 30, 2007.
23 “U.S., Chinese leaders try to advance trade, food safety issues,” Agri-Pulse, May 30,


States to check on whether Chinese exporters had been approved by that
government. 24
FDA officials had told CRS that in FY2006, the overall refusal rate for
shipments from China (food and all other types of FDA-regulated shipments) was
0.15%. They cautioned that the 99.85% of shipments were not necessarily in
compliance, because the agency only has the resources to examine 1% of all line
entries (shipments) into the country.25
William Hubbard, a former FDA deputy commissioner, told National Public
Radio (NPR) in 2007 that total “individual shipments of food and ingredient exports
from China to the United States have gone from 82,000 in 2002 to 199,000 in 2006.
And I’m told by FDA officials that they’re rapidly reaching up to 300,000 this
Chinese Food Safety Challenges
As noted, the FDA OASIS database does not provide answers as to whether
Chinese imports are any less safe than those from other countries. Nonetheless, the
country has come under intense criticism in the wake of several widely publicized
incidents involving adulterated food, agricultural, and medical exports. In early 2007
pet food ingredients from China that contained the chemical melamine — apparently
added to boost the ingredients’ protein levels — sickened or killed many dogs and
cats in North America. The ingredients subsequently were found in some hog,
chicken, and fish feed. A risk assessment indicated the problem posed virtually no
risk to humans, USDA and FDA officials asserted. Another incident attracted
attention in early May 2007, when the Mississippi Commissioner of Agriculture
ordered a number of stores there to stop selling catfish from China after samples
tested positive for antibiotics banned in the United States.
Such concerns are not new. An FDA import inspector was quoted in 1991:
“Some countries we almost never have problems with.... But others, such as India,27
Thailand, China, Korea, and many countries in Africa, require constant vigilance.”
A number of analysts has examined the food safety challenges China faces as
it becomes a major agricultural exporter. USDA economists wrote in 2006:
China emerged in the 1990s as a low-cost exporter of food products such as
vegetables, apples, seafood, and poultry. But in recent years, China’s exports

24 See for example: “Senior Chinese Official Hopes Chinese Actions Will Delay
Legislation,” FDA Week, September 14, 2007.
25 FDA e-mail communication to CRS, June 6, 2007.
26 “Q&A: Why China Tops the FDA Import Refusal List,” accessed May 25, 2007, at
[ ory/ story.php?storyID=10410111].
27 Sharon Snider, “From Psyllium Seeds to Stoneware: FDA Insures the Quality of Imports,”
FDA Consumer Magazine, March 1991.

slowed when shipments of vegetables, poultry and shrimp were rejected for
failing to meet stringent standards in Japan, Europe, and other countries,28
revealing a gap between Chinese and international food safety standards.
Some analysts contend that China’s problems in complying with other —
usually more developed — countries’ safety requirements are typical of those faced
by most developing countries. They point to a number of specific obstacles the
Chinese have encountered in upgrading their safeguards, including:
!the difficulty of standardizing and monitoring production practices
at the farm production level, to which many safety problems can be
traced due to widespread noncompliance with existing regulations
such as environmental rules, and which is composed of 200 million
households typically farming on plots of one to two noncontiguous
!heavy use of fertilizers and pesticides to counteract intensively
cultivated soils and large pest pressures;
!wide use of antibiotics to control diseases in intensive livestock,
poultry, and aquaculture systems;
!industrialization, lax environmental controls, and untreated human
and animal waste in fields and waters, which raise concerns about
toxic, metal, and microbial contaminants in food;
!a fragmented marketing system dominated by millions of small firms
handling small volumes, often on a cash basis with no
documentation or ability to trace products;
!a fragmented regulatory and oversight structure involving 10
national government ministries and little coordination with lower
levels of government, which often have their own, differing
standards for food products; and
!for many commodities and industries, outdated or nonexistent
standards, or standards that are inconsistent with internationally
accepted ones.29
Responsibility for domestic food safety is shared among a number of Chinese
agencies at the national, provincial, and local levels, including the national Ministry
of Agriculture, which supervises the quality of primary agricultural products; and the
Ministry of Health and the State Food and Drug Administration (SFDA), both with
responsibilities in regulating processed foods. Quality assurance for both imports
and exports is under the purview of the General Administration for Quality
Supervision, Inspection and Quarantine (AQSIQ), which also has oversight over all

28 Linda Calvin et al., “Food Safety Improvements Underway in China,” Amber Waves,
November 2006, USDA, ERS. The Codex Alimentarius Commission is the major
international body for encouraging international trade in food while promoting the health
and economic interest of consumers. Codex is a subsidiary of the Food and Agriculture
Organization and the World Health Organization. One of its key functions is to develop
standards, codes of practice, and guidelines for the safety of foods, in accordance with the
SPS Agreement. The Codex website is at [].
29 Calvin. Also, Fengxia Dong and Helen H. Jensen, “Challenges for China’s Agricultural
Exports: Compliance with Sanitary and Phytosanitary Measures,” Choices, 1st quarter 2007.

exports (including food and toys). However, the Ministry of Health and the SFDA
have had “minimal” roles in regulating exports.30
At one 2007 hearing, an FDA official observed that China has some 400,000
food or feed manufacturers. From 12,000 to 15,000 are registered with AQSIQ and
are therefore eligible to export products, yet an estimated one-third of China’s food
exports come from non-registered establishments.31 According to another expert,
China officially has 448,000 food enterprises, 78% of them “cottage industries” with

10 employees or fewer.32

U.S. Efforts to Improve Import Compliance
Administration officials have attempted to reassure Congress that they are
working diligently on plans to improve oversight of all food imports generally and
of Chinese imports particularly. In late 2007, they had unveiled several documents
focused on these objectives.
Food Safety and Import Plans. On November 6, 2007, the Administration
released two separate but related reports. The broader of the two covers the safety
of most imports for consumers, including but not limited to food. This Action Plan
for Import Safety was prepared for the President by the Interagency Working Group33
on Import Safety. The other report is FDA’s Food Protection Plan, which focuses
on food, whether imported or domestically produced, and which contains34
recommendations for food imports that generally parallel those in the import report.
Both plans are oriented toward assessing and prioritizing risks regardless of
where they occur (starting with a product’s origin), and preventing problems rather
than waiting for them to occur. Both plans appear to rely heavily on cooperation with
others, including private industry stakeholders and foreign governments, to assure
safety, but they also propose some new regulations and new legislative authorities
affecting importers and others in the food system. Officials stated that they were

30 House Energy and Commerce Committee, Subcommittee on Oversight and Investigations
staff trip report, “Food from China: Can We Import Safely?” Released October 5, 2007.
The trip report observed, among other things, that the Chinese food supply chain apparently
does not meet international safety standards, and that the Chinese government “appears
determined to avoid embarrassing food safety outbreaks in export markets.”
31 David Acheson, FDA Assistant Commissioner for Food Protection, in response to
questions at a September 26, 2007 hearing before the House Committee on Energy and
Commerce, Subcommittee on Health.
32 Source: Drew Thompson, Director of China Studies and Starr Senior Fellow, The Nixon
Center, “U.S.-China Food Safety and Trade,” September 9, 2007, presentation at a
Woodrow Wilson Center conference, Regulating Food Safety in China.
33 Available at [].
34 Available at []. Both plans are
described in more detail in CRS Report RL34198, U.S. Food and Agricultural Imports:
Safeguards and Selected Issues.

seeking additional funds to help pay for these initiatives as part of the FY2009 budget
Bilateral Memorandum of Agreement. On December 11, 2007, the
Administration announced that it had signed a memorandum of agreement (MOA)
with the Chinese government intended to enhance the safety of food and feed imports
from China. The MOA was the culmination of four sets of meetings with the
Chinese, plus part of a side meeting of President Bush and Chinese leader Hu Jintao
at the September 2007 Asia-Pacific Economic Cooperation (APEC) ministerial in
Sydney, Australia.35 The food and feed MOA states the two countries’ intention “to
establish a bilateral cooperative mechanism” that “may include current and future
registration and certification systems. The mechanism aims to provide the Parties
with information to use in judging whether an imported product meets the
requirements of the importing country.”36
Under the agreement, China is to require exporters to the United States to
register with the Chinese AQSIQ, and to agree to annual inspections to assure that
their goods meet U.S. standards. AQSIQ is to notify FDA of those that fail
inspection and why, and of all companies that have lost their registration status. The
Chinese agency also is to develop both a system for tracing products from source of
production to point of exportation, and a statistically valid testing program. Also
under the agreement, the two countries are to notify one another within 48 hours of
any new public health risks related to food or feed, and AQSIQ is to facilitate FDA
access to, and inspection of, Chinese processing and cultivation sites.
Starting with the first phase of implementation, AQSIQ-issued export
certificates are to be required of exporters of commodities that have high import
refusal rates, specifically low-acid canned products or acidified foods, pet foods,
ingredients of food and feed like wheat gluten and rice protein, and all farmed
seafood except molluscan shellfish. Other commodities could be added during later
phases, according to the MOA annex. The agreement commits the two sides to
forming a working group to develop further implementation details of the plan, with
a final plan due within 120 days, among other specified deadlines.
Stakeholders raised a number of concerns about the agreement. The Consumers
Union asserted that the agreement neglected other Chinese products with
questionable safety records, such as apple juice, and failed to give U.S. inspectors
immediate access to Chinese plants. Several others expressed doubts about China’s
willingness or capacity to meet its obligations, noting that the government already
has strict food standards but has not widely enforced them. Among other questions
are whether the agreement might effectively give unfair preferential treatment for
Chinese over other foreign imports; whether FDA will have adequate resources for

35 Also announced on December 11, 2007, was a second bilateral agreement on drugs and
medical devices.
36 Agreement between the Department of Health and Human Services of the United States
of America and the General Administration of Quality Supervision, Inspection and
Quarantine of the People’s Republic of China on the Safety of Food and Feed, accessed on
December 31, 2007, at [].

oversight and enforcement; and whether the agency has the appropriate legal
authority to share information about U.S. food companies or to demand certificates
from foreign importers.37
On June 18, 2008, the United States and China issued a “Joint Progress
Statement” on implementation of the agreement, noting that the two parties had
established mechanisms for cooperation and communication on food safety events;
developed “concrete steps” toward a system where AQSIQ will electronically certify
to FDA that specific China-exported products to the United States meet FDA safety
and quality standards; and agreed to train Chinese officials on U.S. regulatory
requirements, focusing on inspections and laboratory testing standards.38
Other Bilateral Efforts. FDA’s Center for Food Safety and Nutrition
(CFSAN) website indicates that it has been aggressively pursuing both formal and
informal agreements with foreign government counterparts to achieve mutual
recognition of equivalence of regulatory systems. Another FDA website lists more
than 90 “International Arrangements” with approximately 30 separate foreign
entities, of which 36 appear to be directly food-related. Roughly a third of these39
address aspects of shellfish or other seafood safety. FDA’s agreements with China
apparently do not include any for food, but are in place for lead in tableware.
The Chinese have approved necessary visas to enable FDA to establish
permanent offices in the country, FDA Associate Commissioner for Foods Acheson
told a House hearing in September 2008. The agency intends to place about eight or
nine staffers plus five Chinese nationals in three locations in China, with the first
likely to open in October 2008, he added. Their presence will allow for closer40
oversight and coordination on food and drug safety matters.
Detention of Chinese Seafood. In one significant move last year, FDA on
June 28, 2007, issued an import alert ordering the “Detention Without Physical
Examination” of all of the following aquacultured products from China: catfish, basa
(related to catfish), shrimp, dace (related to carp), and eel.41 FDA said it issued the
notice after targeted sampling during October 2006 through May 2007 “repeatedly
found that farm-raised seafood imported from China were contaminated with
antimicrobial agents that are not approved for this use in the United States.” The
agents are nitrofuran, malachite green, and gentian velvet, which have been found to

37 See for example”U.S.-China Food Safety Deal Could Give China Preferential Treatment,
FDA Week, December 21, 2007.
38 HHS, “United States and China Outline Progress on Agreement on Food and Feed
Safety,” June 18, 2008, press release, accessed on the Internet September 25, 2008, at
[ ess/2008pres/06/20080618a.html ].
39 Both websites accessed May 15, 2007, at [].
40 See for example, “Acheson: China Has Granted Visas for FDA Outpost,” FDA Week,
September 19, 2008.
41 FDA Import Alert #16-13, which may be viewed at [
ora_import_ia16131.html ].

be carcinogenic to laboratory animals; and fluoroquinolones, which when used in
food animals may increase antibiotic resistance in humans, the agency said.
Under such an import alert, FDA detains all covered products until the
importing firm demonstrates, through testing by an independent laboratory, that a
representative sample of their product is free of these contaminants. Although the
FDA has long issued these types of alerts for various imports, they generally are more
limited in scope — for example, to a particular firm or product.
The import alert reiterated that approximately 80% of U.S. seafood consumption
is from imports and that over 40% of these imports come from aquaculture
operations. Shrimp and catfish are two of the top 10 most frequently consumed
seafood products. China is the largest aquaculture producer in the world, with 70%
of total production, and the third largest exporter to the United States. The alert
observes: “As the aquaculture industry continues to grow and compete with wild-
caught seafood products, concerns regarding the use of unapproved animal drugs and
unsafe chemicals and the misuse of animal drugs in aquaculture operations have
increased substantially.”
Chinese Efforts to Address Food Safety
Chinese government officials appear to have launched a series of major
initiatives to bolster their food safety programs, notwithstanding their assertions,
throughout 2007 and 2008, that their products are safe. To deal with the most recent
crisis regarding tainted dairy products, the Chinese agriculture ministry announced
on September 23, 2008, that it would require all milk dealers to register and would
conduct regular inspections of milk to ensure there is no more tampering. Earlier, the
Chinese said they had fired their top inspection official.
In 2007, officials announced their intention to update a 1995 consumer food
law, and in 2006 the Chinese legislature adopted a national framework for building
an agricultural product safety system. The Chinese have said they do require
registration of all land and processing facilities used for exported products, and
exporters must have facilities that can test for pesticide residues. The government
also says it does sample and test products for export to help ensure they meet foreign
buyers’ standards.42
China also has been encouraging investment, including foreign direct
investment, in production and processing to improve technology, marketing and
management skills, and transportation and infrastructure. Six types of processed
foods — canned food, aquatic products, meat and meat products, frozen vegetables,
fruit/vegetable juice, and some frozen convenience foods — reportedly are to be
manufactured under HACCP (hazard analysis and critical control point) standards.43

42 Calvin.
43 Dong.

HACCP is a system of assessing risks, determining the points at which they might
occur during production, and instituting measures to prevent them.44
At a May 31, 2007, news conference, a Chinese official also pointed to the death
sentence handed down to the former head of the government’s food and drug safety
agency, as an example of its determination to improve product oversight. The agency
head had been convicted of taking bribes for approving potentially dangerous drugs.
He reportedly was executed on July 10, 2007.45
In late June 2007, one Chinese government agency reportedly announced the
closure of 180 food manufacturers that it said had been using industrial materials
such as dyes, mineral oils, hydrochloric acid, paraffin, and formaldehyde in a variety
of food products, including flour, candies, seafood, pickles, and biscuits. Another
agency reportedly claimed to have closed 152,000 unlicensed food manufacturers and
retailers in 2006 for making counterfeit or low-quality products.
According to U.S. agricultural attache reports, China’s AQSIQ announced that
it would begin affixing inspection and quarantine labels to all food product packages
for export after inspection, effective September 1, 2007.46 USDA and other China
experts observe that China has made its oversight of food exports the highest priority.
They note that China has restricted eligibility to a relatively small proportion of its
estimated 448,000 food processors.
Other announcements have included a Chinese State Council regulation
intended to intensify controls over food product producers and distributors, where
more records would be made public, new higher fines would be levied on food
exporters who violate regulations, and a “blacklist” would be established for both
exporters and domestic importers who distribute unqualified food products. The
regulation reportedly notes that local governments are mainly responsible for food
safety oversight.47
Other reported actions include the designation of the equivalent of $1.6 billion
to improve food and drug supervision by the SFDA, and new rules to tighten
oversight of food and drug processors including their acquisition of raw materials.48
Meanwhile, another agency, the Standardization Administration of China, announced
at a July 2007 press conference that it planned to revise by 2010 as many as 4,000
food safety standards, notably for food additives, dairy, meat, eggs, and fisheries.

44 FDA information on HACCP is at [].
45 “China Executes Former Head of Food Safety Agency,” Wall Street Journal, July 10,


46 For details of the change see USDA, FAS, China to attach inspection and quarantine
labels for food exports, Gain report CH7059, July 23, 2007, accessed on the Internet at
[ ht t p: / / www.f a gai nf i l e s/ 200707/ 146291796.pdf ] .
47 This announcement and other recent China food safety news is covered in: USDA, FAS,
Agricultural Situation News Flash I.28, GAIN report CH7065, August 10, 2007, accessed
on the Internet at [].
48 Ibid.

Whether these commitments applied to other Chinese bodies such as AQSIQ was
The same AQSIQ regulation (see above) also was to impose new requirements
on importers into China. U.S. exporters already were encountering sanitary barriers
to trade first imposed in July 2007 by Chinese officials. At that time, they announced
that meat and poultry imports shipped by some U.S. companies were being
suspended. These included chicken products that, China asserted, contained
Salmonella bacteria (although U.S. interests have long noted that proper cooking
destroys the bacteria), and pork products that contained an unapproved feed additive
(which appears to be legal in the United States).50 Shortly after that, poultry exports
from seven U.S. states were banned from China due to the presence of Low
Pathogenic Avian Influenza (LPAI), a move that the United States asserted was not
based on sound science.51 In early October 2007 China reportedly rejected 47 tons
of U.S. frozen sardines that were said to be contaminated with Listeria.
Some U.S. interests contended that these actions were in retaliation for U.S.
complaints about the safety of Chinese goods. Others maintain that the Chinese are
seeking to demonstrate to their own consumers that they are protecting them from
unsafe products, including imported goods. For example, they also have blocked
poultry imports from Brazil based on sanitary concerns.
Congressional Consideration
Members of Congress have expressed sharp criticism both of China’s food
safety record and of U.S. efforts to insure the safety of that country’s
Among panels that have examined the issue in the 110 Congress are the House
Agriculture Committee; the House Energy and Commerce Committee’s
Subcommittee on Oversight and Investigations, and its Subcommittee on Health; the
House Ways and Means Subcommittees on Oversight and on Trade ; the Agriculture
Subcommittee of the House Appropriations Committee; the Senate Commerce
Committee; and the Senate Health, Education, Labor, and Pensions Committee.
A number of bills with food import safety provisions were introduced in 2007,
and several passed. For example, Section 1009 in the Food Safety title (X) of the
Food and Drug Administration Amendments Act of 2007 (H.R. 3580; P.L. 110-85),
passed in September 2007, requires an annual report to Congress on the number and
amount of FDA-regulated food products imported by country and type of food, the

49 USDA, FAS, Food and Agricultural Import Regulations and Standards, Country Report
— Mandatory Update, GAIN report CH7066, August 16, 2007, accessed on the Internet at
[]. This report is intended to
catalogue the key standards affecting imports for the Chinese market, according to FAS.
50 Various news reports, including Food Chemical News, July 2, 2007; The Wall Street
Journal, July 16, 200; and Reuters, July 15, 2007.
51 USDA, FAS, Poultry and Products Annual Report, GAIN report CH7077, September 26,

2007, accessed at [].

number of inspectors and inspections performed, and aggregated data on inspection
findings, including violations and enforcement actions. Elsewhere, Division A of the
Consolidated Appropriations Act, 2008 (H.R. 2764), provides funding for the balance
of the fiscal year for both FDA and FSIS. A provision of this act prohibits FSIS from
implementing an FSIS rule that would allow certain poultry products to be imported
from China. This proposal to permit some types of processed poultry had been
published in the November 23, 2005, Federal Register.
Approximately a dozen other food safety bills containing one or more provisions
that address food import safety were pending in 2008. Several focus almost
exclusively on the issue. Many (including H.R. 2997, S. 1776, H.R. 1148/S. 654,
H.R. 2108/S. 1274, H.R. 3610, and H.R. 3624) propose that importing
establishments, and/or the foreign countries in which they are located, first receive
formal certification from U.S. authorities that their food safety systems demonstrably
provide at least the same level of safety assurances as the U.S. system. Under some
of these bills, certification could be denied or revoked if foreign safeguards are found
to be insufficient, unsafe imports are discovered, or foodborne illnesses are linked to
such products. A number of the bills also propose the collection of user fees from
importers to cover the costs of inspecting foreign products at the borders.
Some bills seek to require more physical inspections and testing by FDA at the
border or within other countries, to authorize more research into inspection and
testing technologies, or to restrict imports to specific ports. H.R. 3100 is another
measure with import safety provisions. S. 2418 would require USDA to provide
public notification whenever smuggled food products are identified in commerce, and
to provide public notification on all recalled food products, using methods prescribed
in the bill. The bill would require private laboratories that conduct tests on FDA-
regulated imports to be certified by the agency, under a fee-funded process for
certification and audits to be developed by FDA. Laboratories would have to submit
to the agency the results of all tests they conducted. (These bills are described in
more detail in CRS Report RL34198, by Geoffrey S. Becker.)
In 2008, attention focused on two comprehensive safety bills, one by Senator
Durbin (S. 3385) and another a draft proposal being circulated by Representative
Dingell. Title III of the Durbin bill is specific to imported foods, with provisions
such as a requirement that each importer establish a food safety supplier verification
program; authorization to permit importers to qualify for expedited review and entry
if they exceed minimum safety standards; and explicit authority for HHS (FDA) to
require export certificates for foods determined to be of higher risk, with certificates
to be issued in the foreign countries of origin by qualified “certifying entities.”
Title III also would direct FDA to establish a system to accredit qualified third
parties that could certify that food facilities are in compliance with U.S. standards.
Such parties could include foreign governments, states, and foreign or domestic
cooperatives. Other notable provisions in the Durbin bill’s import title would
authorize HHS to enter into agreements with foreign governments that would enable
FDA to inspect foreign facilities and to deny entry of food imports from those
facilities that impede such inspections; give FDA additional authority to review
foreign food safety systems; and require FDA to develop a comprehensive plan to
improve the regulatory capacities of foreign governments.

Import-specific provisions in the Dingell draft include a requirement for all
importers of food, drugs, devices and cosmetics to register with the FDA and to pay
an annual fee of $10,000; the establishment of a corps of inspectors dedicated solely
to import inspections; more stringent country-of-origin labeling requirements; and
limiting, within five years, all imports (of FDA-regulated foods and other products)
to ports of entry that are located near a federal food testing laboratory. There are now
a total of 13 FDA field laboratories but well over 300 ports of entry.
Recent developments with food imports also spurred calls for implementation
of mandatory country-of-origin labeling (COOL) for fresh meats, produce and
peanuts, taking effect as of September 30, 2008. The omnibus 2008 farm bill (P.L.
110-246) maintained this date, but it added more covered commodities including
chicken and modified some labeling and record-keeping requirements. (For further
information on COOL, see CRS Report RS22955, Country-of-Origin Labeling for
Foods, by Geoffrey S. Becker.)