U.S. Food and Agricultural Imports: Safeguards and Selected Issues
Prepared for Members and Committees of Congress
U.S. officials continue to assert that the U.S. food supply, including the portion provided through
imports, is among the safest in the world. One challenge has been how to keep it safe in the face
of steadily rising imports, a result of globalization and consumer desire for a wider variety of
foods year-round. The issue of import safety was the focus of numerous congressional hearings thth
and bills in the 110 Congress, and is expected to be high on the policy agenda of the 111
Does the U.S. safety system, first created at a time when most Americans obtained their foods
domestically, adequately protect public health? What, if any, changes should be made to enhance
the safety of food imports? Critics argue that major reforms are necessary because the present
programs are both poorly designed and inadequately funded to meet today’s challenges. An
opposing argument is that imported foods already are subject to the same safety standards as—
and pose no greater hazards than—domestically produced foods. An early argument of the Bush
Administration was that smarter allocation of existing resources, and the food industry’s own
controls, could and should be capable of addressing any problems.
In early December 2007 a science advisory board of the U.S. Food and Drug Administration
(FDA) Science Board concluded that the agency ‘s overall appropriation, now at about $1.5
billion, should be more than doubled in the next several years if it is to meet its current
responsibilities, including but not limited to food safety. Congress did provide the FDA with some
increased funding for FY2008 and part of FY2009.
The Bush Administration in November 2007 also had issued new policy recommendations on
food safety and on import safety. Although these recommendations received some attention in the th
110 Congress, by the second session many stakeholders were focusing on draft bills circulated
by the chairmen of the House Energy and Commerce Committee and the Senate Health,
Education, Labor, and Pensions Committee. The proposals differed in detail, but both sought
broad reforms in FDA’s oversight of food and drug safety, including of imports. Another
comprehensive bill, S. 3385 also called for broad reforms in food safety oversight. Numerous th
other food safety bills in the 110 Congress addressed one or more aspects of food import safety.
Elements of these bills could re-emerge in legislative proposals expected to be introduced into the th
Introduc tion ..................................................................................................................................... 1
Food and Agricultural Imports Increasing.......................................................................................1
Federal Oversight Responsibilities..................................................................................................3
International Trade Considerations..................................................................................................7
FDA Import Refusals.......................................................................................................................8
FY2007 and FY2008 Refusals..................................................................................................8
Past Refusal Data.....................................................................................................................11
FSIS Import Refusals....................................................................................................................12
Melamine in Pet Food Ingredients..........................................................................................12
Seafood Safety Concerns........................................................................................................13
Melamine in Human Foods.....................................................................................................13
Chinese Food Safety Challenges.............................................................................................15
Efforts to Improve Chinese Compliance.................................................................................16
Bilateral Memorandum of Agreement..............................................................................17
Other Chinese Initiatives...................................................................................................18
Bush Administration Initiatives.....................................................................................................19
Import and Food Safety Plans.................................................................................................19
Status of the Plans...................................................................................................................20
Selected Legislative Issues and Options........................................................................................20
Access to Foreign Facilities....................................................................................................22
Mandatory Recall Authority and Access to Records...............................................................22
Third-Party Inspections and Testing........................................................................................22
Funding and Fees....................................................................................................................23
Other Proposed Legislative Changes......................................................................................23
Table 1. Leading Suppliers of U.S. Agricultural and Seafood Imports, FY2008............................2
Table 2. FDA Refusals Among Leading Country Importers, FY2007............................................9
Table 3. FDA Refusals Among Leading Country Importers, FY2008..........................................10
Table 4. Imported Meat and Poultry Products Presented for Inspection and Refused Entry,
Author Contact Information..........................................................................................................24
Officials continue to assert that the U.S. food supply, including the portion imported, is among the
safest in the world. One challenge has been the steady increase in imports, a result of
globalization and consumer desire for a wider variety of foods year-round. With this growth have
come new concerns about whether current federal programs sufficiently ensure the safety of these
imports. Import alerts in 2007 and 2008 targeting adulterated pet food ingredients, farmed
seafood, and dairy products and ingredients, all from China, are among the incidents that th
heightened interest in the issue in the 110 Congress.
Do U.S. safeguards, generally created at an earlier time when most Americans obtained their
foods domestically, remain sufficient to protect public health? What, if any, changes should be
made to enhance the safety of food imports? Critics argue that major reforms are necessary
because the present programs are both poorly designed and inadequately funded to meet today’s
challenges. Those who oppose major changes assert that imported foods already are subject to the
same safety standards as—and pose no greater hazards than—domestically produced foods. They
also contend that smarter allocation of existing resources, and the food industry’s own controls,
can and should be capable of addressing any problems that arise.
The issue was explored at numerous congressional hearings in 2007 and 2008, and Members of
Congress introduced a variety of bills to modify or overhaul the current system. Some sought
broad reforms in the U.S. Food and Drug Administration’s (FDA’s) oversight of both food and
drug safety, including of imports. (The U.S. Department of Agriculture oversees the safety of
most meat and poultry; FDA all other foods). The House Energy and Commerce Committee and
the Senate Health, Education, Labor, and Pensions Committee, the likely starting points for FDA th
food safety reform, did not mark up comprehensive legislation in the 110 Congress—but are th
widely expected to consider major bills in the 111 Congress.
The Bush Administration had released, on November 6, 2007, its own import safety plan and an
accompanying food protection strategy. These documents made a number of recommendations,
some of them entailing new legislative authority and additional funding, which the Bush
Administration requested in its FY2009 budget submission for FDA. (FDA appropriations usually
are provided each year as part of the Agriculture, Rural Development, FDA, and Related
Agencies Appropriations Act, not by the authorizing committees.) It was unknown in late 2008
whether an Obama Administration would incorporate elements of the Bush plan into its own food
safety strategy and funding recommendations.
U.S. imports of agricultural and seafood products from all countries increased from 35.6 million
metric tons (MMT) in FY1997 to 48.2 MMT in FY2007, or by 35%. The increase by value was
94%, from $43 billion in FY1997 to $83.6 billion in FY2007. 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, and various seafood products. Agricultural and seafood 1
imports increased again in FY2008, to 50.7 MMT valued at $93 billion.
1 U.S. Department of Agriculture (USDA), Foreign Agricultural Service (FAS), U.S. Trade Internet System, BICO
Table 1 shows that the United States’ NAFTA (North American Free Trade Agreement) partners,
Canada and Mexico, were by far the largest suppliers of food, agricultural, and seafood imports in
FY2008—with a combined one-third share of total imports. The percentage share of all other
leading importers was in the single digits.
Table 1. Leading Suppliers of U.S. Agricultural and Seafood Imports, FY2008
(value in billion U.S. dollars)
Country Agricultural Seafood Total Share (%)
1. Canada $17.935 $2.278 $20.213 21.7
2. Mexico 10.761 0.482 11.243 12.1
3. China 3.427 2.027 5.455 5.9
4. Thailand 1.917 1.831 3.748 4.0
5. Indonesia 2.669 1.052 3.721 4.0
6. Italy 3.296 0.009 3.304 3.6
7. Chile 1.961 0.993 2.954 3.2
8. Brazil 2.598 0.103 2.701 2.9
9. Australia 2.404 0.072 2.477 2.7
10. Ireland 2.386 0.006 2.392 2.6
11. France 2.380 0.012 2.392 2.6
12. Netherlands 2.156 0.040 2.196 2.4
13. Malaysia 1.710 0.201 1.911 2.1
14. New Zealand 1.739 0.128 1.867 2.0
15. India 1.533 0.228 1.762 1.9
16. Colombia 1.716 0.041 1.757 1.9
17. Vietnam 0.691 0.765 1.456 1.6
18. Ecuador 0.722 0.615 1.338 1.4
19. Germany 1.279 0.005 1.284 1.4
20. Costa Rica 1.201 0.077 1.278 1.4
21. Guatemala 1.259 0.017 1.276 1.4
22. Argentina 1.177 0.084 1.261 1.4
23. Spain 1.189 0.039 1.228 1.3
24. Philippines 0.896 0.262 1.158 1.2
25. Peru 0.778 0.089 0.868 0.9
World Total 79.317 13.720 93.0379 100.0
Source: USDA, Foreign Agricultural Service (FAS), BICO Import Commodity Aggregations.
(Bulk, Intermediate, and Consumer-Oriented) data.
Not all agricultural imports enter the human food supply; some products are used as ingredients
in pet food and animal feed, in manufactured goods (e.g., rubber), and in the nursery plant trade.
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
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); and 54% of all 2
tree nuts (40% in 1995).
Two federal agencies—USDA’s Food Safety and Inspection Service (FSIS) and the U.S.
Department of Health and Human Services’ Food and Drug Administration (FDA)—are
responsible for the majority of the total funding and staffing of the government’s food regulatory
system. For imports, FSIS relies on a very different regulatory system than FDA, including a
differing approach to addressing equivalence, as described below. Also important are USDA’s
Animal and Plant Health Inspection Service (APHIS), which is responsible for protecting plant
and animal resources from domestic and foreign pests and diseases, and the Department of
Homeland Security (DHS), which is responsible for coordinating agencies’ food security 3
activities, including border inspections by DHS’s U.S. Customs and Border Protection (CBP).
The FDA’s food regulatory authority comes chiefly from the Federal Food, Drug, and Cosmetic 4
Act (FFDCA), as amended (21 U.S.C. 301 et seq.). This authority makes the agency responsible
for the safety of virtually all domestic and imported articles used for food and drink, except meat
and poultry (see “FSIS Role,” below); these include animal as well as human foods. FDA-
regulated foods may be deemed adulterated or misbranded for a variety of statutorily prescribed
reasons. For example, a food may be deemed adulterated if it contains an added poisonous or
deleterious substance or an unsafe food additive or if the food was prepared, packed, or held
under insanitary conditions whereby it may have become contaminated or may have been 5
rendered injurious to health. Of approximately 60,700 domestic food facilities (such as
manufacturers, warehouses, and shippers), FDA designates about 8,000 as “high risk,” based on 6
the types of foods they handle and/or past performance. In general, FDA attempts to conduct
annual inspections of these facilities; non-high risk establishments are inspected, on average, once
2 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%.
3 In total, as many as 15 federal agencies administer at least 30 laws related to food safety.
4 Portions of this section and the following section are based on Olsson, Frank and Weeda, P.C., and The Food
Institute, Importing Food into the United States: A Regulatory Guide, 2007. Data sources for this section, unless noted:
David Acheson, Assistant Commissioner for Food Protection, U.S. Food and Drug Administration, testimony before
the House Agriculture Committee, May 9, 2007; and House Appropriations Committee hearings on Agriculture
Appropriations for various years.
5 21 U.S.C. § 342(a)(2).
6 Source: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for
2008, Part 5, hearings before a Subcommittee of the Committee on Appropriations, House of Representatives, 110th st
Cong., 1 sess.
every 5 years, according to FDA, although other estimates—including another of FDA’s—7
indicate an inspection frequency of once every 10 years.
All domestic and foreign food manufacturing facilities must adhere to FDA’s regulations on Good
Manufacturing Practices (21 C.F.R. part 110), which address safe handling and plant sanitation.
Exempt are establishments such as farms engaged solely in harvesting, storing, or distributing
raw agricultural commodities normally cleaned or otherwise treated before consumption.
Section 801 of the FFDCA empowers the FDA to refuse entry to any food import if it “appears,”
based on a physical examination or otherwise, to be adulterated, misbranded, or in violation of the 8
law. 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 is to help
inspectors to determine a shipment’s relative risk and whether it needs closer scrutiny (i.e., a
wharf or physical examination, and/or testing). FDA inspectors are to work closely with CBP 9
officials on these tasks.
If closer examination is not deemed necessary, FDA allows the product to enter U.S. commerce.
A shipment found to be noncompliant is subject to a number of corrective actions, such as
relabeling or reconditioning to bring it into compliance, refused entry, or even seizure and
destruction. Sometimes, the agency subjects an import to “detention without physical 10
examination,” based on past history or other information indicating that it may be violative.
Such detention compels the importer to demonstrate to FDA that the product is safe before it can
enter U.S. commerce. Examples in 2007 were the detention of all Chinese plant protein products
(including wheat gluten and rice gluten, destined for pet foods) after some were found to contain
melamine, an unapproved substance; and of all farm-raised seafood from China (specifically,
shrimp, catfish, basa, dace, and eel) until the shippers of these products could demonstrate that
they are free of unapproved drug residues. In 2008, the FDA issued a detention import alert for all
milk products, milk-derived ingredients, and food products containing milk from China until they
can demonstrate that they do not contain melamine or cyanuric acid.
The volume of FDA-regulated imports has increased substantially in the past decade. The agency
recorded more than 8.2 million imported food “lines” in FY2007 compared with fewer than 2.8
7 For example, FDA Science and Mission at Risk, a November 2007 report prepared by a subcommittee of the FDA
Science Board (the Commissioner’s top advisory group) cited (on p. 21) an FDA estimate that “ ... at most, it inspects
food manufacturers once every 10 years ... “ Also, the FDA Food Protection Plan (November 2007) stated that there
were over 136,000 registered domestic food facilities and approximately 189,000 foreign facilities that manufacture,
process, pack, or hold food. These figures are inflated, because facilities engaged in more than one activity are counted
multiple times. The Food Protection Plan is discussed later in this CRS report.
8 21 U.S.C. § 381(a).
9 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) greatly expands
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, among other provisions.
10 FDA’s authority to detain without physically inspecting an article derives from 21 U.S.C. § 381(a), which states that
FDA must refuse admission of certain imports into the United States “[i]f it appears from the examination of such
samples or otherwise” that such samples are adulterated, misbranded, or otherwise in violation of the law (emphasis
million entry lines in FY1997. Just over 1% of these lines were physically examined and/or 11
tested. In 2007 congressional hearings, witnesses testified that 450 inspectors must cover more 12
than 300 ports of entry.
FDA’s ability to operate within other countries appears to be limited. 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. Further, FDA asserts that it lacks the
staff and funding to increase its presence overseas, regardless of whether it might have the legal
authority to do so. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) had a budget of
$457 million and staff of 2,700 (full-time equivalent or FTE) in FY2007, of which $298 million 13
and 1,900 FTEs were in the field. For FY2008, the FDA foods budget was $577 million, which 14
included a mid-year supplemental appropriation of $67 million.
In a hearing before the House Agriculture Committee, FDA’s chief food officer testified that the
agency theoretically has the authority to require equivalency for imports but that FDA’s situation
is significantly more complex than USDA’s (the latter regulates fewer types of food products; see 15
CFSAN has stated on its website that it is “aggressively pursuing both informal and formal
agreements with foreign government counterpart officials including Memoranda of
Understanding for mutual recognition of equivalence of regulatory systems.” Another FDA
website lists nearly 100 “International Arrangements” with approximately 30 separate foreign
entities, of which about a third appear to be directly food-related. Roughly a third of the food-16
related arrangements address aspects of shellfish or other seafood safety. However, these are not
the same as formal equivalency requirements (see “FSIS Role,” below).
FSIS regulates the safety and labeling of most domestic and imported meat and poultry, under the
Federal Meat Inspection Act (FMIA) as amended (21 U.S.C. 601 et seq.) and the Poultry Products 17
Inspection Act (PPIA) as amended (21 U.S.C. 451 et seq.). Inspectors are to be present at all
times in slaughter plants and for at least part of each day in establishments that further process
meat and poultry products. They are to examine all animals destined for human food both before
11 Source: FDA briefing for Senate staff, February 8, 2008. FDA FY2009 budget materials state that 94,743 import
food field exams were conducted in FY2007. For definition of “line,” see “FDA Import Refusals” later in this report.
12 See for example hearings held before subcommittees of the House Committee on Energy and Commerce, July 17,
September 26, and October 11, 2007.
13 Source: FDA Science and Mission at Risk, report of the Subcommittee on Science and Technology, Prepared for the
FDA Science Board, November 2007.
14 Source: CRS Report RL34638, FDA FY2009 Appropriations, by Susan Thaul et al.
15 “Officials defend federal response to melamine contamination,” Food Chemical News, May 14, 2007. GAO had
suggested in 1998 that border inspections alone were ineffective, but that FDA lacks the authority to mandate
equivalency (RCED-98-103, Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent and
16 The arrangements were accessed December 2008 at http://www.fda.gov/oia/default.htm.
17 FSIS inspects the major red meat and poultry species and their products; catfish was added to FSIS’s responsibilities
by the 2008 farm bill (P.L. 110-246; § 11016). FDA has jurisdiction over all meat and poultry not inspected by FSIS.
The agencies share responsibility for egg safety, under the Egg Products Inspection Act, as amended (21 U.S.C. § 1031
et seq.). FSIS covers processed egg products; FDA covers most whole eggs.
and after slaughter, and to ensure that plants are operating in a sanitary manner, under an FSIS-
approved safety plan.
Under Section 20 of the FMIA and Section 17 of the PPIA, FSIS also is responsible for
determining the equivalence of other countries’ meat and poultry safeguards. A foreign plant
cannot ship products to the United States unless FSIS has determined that its country has a meat
and/or poultry program that provides a level of protection that is at least equivalent to the U.S. 18
system. FSIS visits the exporting country to review its rules and regulations, meets with foreign
officials, and accompanies them on visits to establishments. When a foreign program is approved,
FSIS relies on that government to certify eligibility of, and to inspect, the establishments. FSIS
periodically reviews foreign government documents and conducts on-site audits at least annually
to verify continuing equivalence.
In addition, FSIS operates a reinspection program at 150 import houses located near
approximately 35 border entry points. Agency inspectors review all import records, aided by a
computerized sampling program, the Automated Import Information System (AIIS). This system
generates inspectors’ actual examination assignments based on what the agency believes to be the
relative risks of particular product types and/or countries. It also can identify shipments that are to
be denied reinspection because, for example, the foreign country or particular plant is not eligible
to ship to the United States, or the product has not been certified to enter. Inspectors next are
responsible for ensuring that all other imports are in acceptable condition, properly labeled, and
accurately counted. This can include opening and physically examining boxes for physical
defects, and collecting samples for laboratory testing for contaminants. FSIS can take a number of
actions when violative products are found. Products that pass are released into interstate
commerce; most are bulk products for further processing at U.S. plants, which are under 19
continuous FSIS inspection.
Meat and poultry imports have increased significantly, from nearly 2.3 billion pounds presented
for inspection in FY1996 to nearly 3.9 billion pounds in FY2007. Approximately 2.5 billion
pounds were presented during the first nine months of FY2008 (i.e., through June 30). FSIS
estimated that it physically had examined approximately 20% of all such imports in FY1996,
compared with approximately 10% in more recent years (after implementation of the AIIS in the 20
early 2000s). About 4% of imports undergo microbiological testing, according to USDA.
In FY2008, FSIS had a total budget of approximately $1 billion (appropriated and user fees) and
a staff of 9,400, of which 7,800 were in about 6,300 meat and poultry plants nationwide. The
agency’s international food safety budget that year was approximately $20 million, more than half
of which went for border reinspections. Other portions were devoted to evaluating foreign
programs and to facilitating U.S. exports. The total international staff numbered an estimated 150, 21
although a significant number were assigned to non-border duties.
18 List of foreign establishments in the 34 eligible countries accessed November 2008 at http://www.fsis.usda.gov/
19 See CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues, by Geoffrey S. Becker.
20 The percentage tested is from comments by Dr. Richard Raymond, Undersecretary for Food Safety, November 7,
2007, before the House Agriculture Subcommittee on Livestock, Dairy, and Poultry.
21 House Appropriations Committee hearings on agriculture appropriations for various years.
Most meat and poultry imports also must be accompanied by a veterinary permit, which APHIS
administers under authority of the Animal Health Protection Act (AHPA; 7 U.S.C. 8301 et seq.).
Under the Plant Protection Act (PPA; 7 U.S.C. 7701 et seq.), APHIS also requires phytosanitary
certificates for many plants and plant product imports, and more detailed import permits for most
foreign fruits and vegetables. Both laws are intended to ensure that imports are free of foreign
diseases or pests that would threaten U.S. animal or plant resources. APHIS’s border inspection
function was transferred to DHS by the Homeland Security Act of 2002 (P.L. 107-296), but
APHIS maintains most other AHPA and PPA responsibilities.
U.S. food safety programs operate within the basic constraints of internationally accepted trade
rules. Any newly adopted measures, such as those discussed later in this report, would likely be
closely scrutinized by U.S. trading partners for their adherence to such agreements. More
specifically, the United States is a signatory to multilateral trade rules which allow governments
to adopt, unilaterally, any measures to protect human, animal, or plant life or health. In doing so,
however, they are not to be discriminatory or used as disguised protectionism.
This principle was clarified in 1994 when most major trading nations including the United States
adopted, along with other so-called Uruguay Round Agreements, the “Agreement on the
Application of Sanitary and Phytosanitary (SPS) Measures.” This document sets out the basic
rules for ensuring that each country’s food safety and animal and plant health laws and
regulations are transparent, scientifically defensible, and fair. The United States also has signed,
or is negotiating, numerous regional and bilateral free trade agreements (FTAs) that may contain
SPS language. Such language in most of the FTAs generally references the signing parties’ rights
and obligations under the multilateral SPS agreement.
The United States also participates in the three major international scientific bodies designated by
the WTO to deal with SPS matters. One, the Codex Alimentarius Commission, focuses on human
food safety. The others are the Office of International Epizootics (OIE) for animal health and
diseases, and the International Plant Protection Convention (IPPC) for plant health. These bodies
meet regularly to discuss threats to human and agricultural health, evaluate SPS-related disputes,
and develop scientifically based SPS standards. Such standards can provide guidance for
countries designing their own national SPS measures, and help resolve trade disputes.
Although U.S. and World Trade Organization (WTO) officials frequently cite the benefits of SPS
cooperation under trade agreements, some, among them food safety and environmental advocacy
organizations, have been skeptical. They have argued that implementation of the agreements can
result in “downward harmonization” rather than upgraded health and safety standards. Defenders
counter that trade rules explicitly recognize the right of individual nations to enact stronger
protections than international guidelines if they believe they are appropriate and are justified by 22
scientific risk assessment.
22 These arguments are covered at greater length in CRS Report RL33472, Sanitary and Phytosanitary (SPS) Concerns
in Agricultural Trade, by Geoffrey S. Becker.
Using its 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 does so only for the most recent 12
months, i.e., only one year’s worth of refusals. (Also listed in the refusal reports, but not
examined here, are other FDA-regulated products: drugs, medical devices, and vitamins.) CRS
examined the data for FY2007 and FY2008 (i.e., October through September of each year).
For each import line, the system provides the name of the source company and the reason for
refusal. A “line” is a portion of an import shipment that is listed separately on that import’s entry
document. An item in a shipment must have a separate line if its tariff description differs from
other items in that shipment. 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 correspond directly to the categories reported through the USDA trade databases (used for
Table 1, above).
Efforts are under way to improve the collection and use of FDA import data. The agency reported
in late 2008 that it was working on an advanced screening system it calls the Predictive Risk-
Based Evaluation for Dynamic Import Compliance Targeting (PREDICT). Elsewhere, Section
1009 of the Food and Drug Administration Amendments Act of 2007 (P.L. 110-85) now requires
an annual report to Congress on the number and amount of FDA-regulated food products
imported by country and type of food, the number of inspectors and inspections performed, and 23
aggregated data on inspection findings, including violations and enforcement actions.
Mindful of limitations of the OASIS data, CRS prepared a tabulation of the refusals, focusing on
nearly 40 categories of FDA-regulated food and food-related products. For the entire FY2007,
FDA logged a total of more than 8,400 refusals. This represents approximately one-tenth of one
percent of the more than 8.2 million lines entered into OASIS during the same period. The
countries involved in the most refusals were India and Mexico, each with approximately 1,150,
China with more than 700, and the Dominican Republic with approximately 650. Indonesia and
Vietnam each logged nearly 400. (See Table 2.)
In FY2008, total refusals increased to 9,600 (total food entries were not available at the time this
report was updated). Mexico logged the most refused lines in FY2008 with 1,393, followed by
India with 1,052, the United Kingdom with 1,034, and China with 697. Indonesia and Canada
each had approximately 400 in FY2008. (See Table 3.)
It is important to note that a higher relative number of refusals does not necessarily indicate that
one country’s products are less safe, or its food safety system less rigorous than that of another
country. The country simply might be a more important source of U.S. agricultural and/or seafood
imports. Mexico, for example, is the second most important exporter to the United States. On the
23 Other food safety provisions in the law affect imported as well as domestic foods. See CRS Report RS22779, Food
Safety: Provisions in the Food and Drug Administration Amendments Act of 2007, by Donna V. Porter.
other hand, Canada, which exports more food and agricultural products to the United States than
any other country, had fewer refusals than a number of countries with fewer imports in dollar thth
value. India’s import value ranked 16 in FY2007 and 15 in FY2008, but its shipments (as
measured by lines) were more frequently refused U.S. entry than most other countries. And, as
Table 3 implies, the United Kingdom is not among the top 25 sources of U.S. food imports, but
registered a high number of refusals in FY2008. The United Kingdom does export many types of
confectionary items, among other products, to the United States.
Table 2. FDA Refusals Among Leading Country Importers, FY2007
(value of agricultural and seafood in billion U.S. dollars)
Country U.S. Import U.S. Import FDA Refusals % Of All FDA
Share (Value) Share (%) (no. lines) Refusals
1. Canada 16.946 20.3 233 2.8
2. Mexico 10.419 12.5 1,144 13.5
3. China 4.849 5.8 731 8.6
4. Thailand 3.322 4.0 226 2.7
5. Italy 3.000 3.6 251 3.0
6. Chile 2.950 3.5 31 0.4
7. Indonesia 2.789 3.3 362 4.3
8. Australia 2.709 3.2 39 0.5
9. Brazil 2.367 2.8 132 1.6
10. Netherlands 2.325 2.8 70 0.8
11. Ireland 2.227 2.7 4 *
12. France 2.129 2.5 175 2.1
13. New Zealand 1.791 2.2 8 *
14. Colombia 1.552 1.9 52 0.6
15. India 1.369 1.6 1,156 13.7
16. Vietnam 1.335 1.6 385 4.6
17. Costa Rica 1.279 1.5 20 0.2
18. Ecuador 1.259 1.5 84 1.0
19. Argentina 1.207 1.4 79 0.9
20. Malaysia 1.195 1.4 33 0.4
21. Spain 1.187 1.4 46 0.5
22. Germany 1.163 1.4 18 0.2
23. Guatemala 1.043 1.2 87 1.0
24. Philippines 0.862 1.0 176 2.1
25. Peru 0.734 1.0 43 0.5
World Total 83.649 100.0 8,456 100.00
Source: Prepared by CRS based on FAS BICO Import Commodity Aggregations (first three columns) and FDA
OASIS data (last two columns). A line is all or part of a shipment of no uniform size, so care should be used in
attempting any comparisons between countries, or between a country’s import value and its number of refused
lines. Asterisk (*) denotes less than one-tenth of one percent.
Table 3. FDA Refusals Among Leading Country Importers, FY2008
(value of agricultural and seafood in billion U.S. dollars)
Country U.S. Import U.S. Import FDA Refusals % Of All FDA
Share (Value) Share (%) (no. lines) Refusals
1. Canada $20.213 21.7 392 4.1
2. Mexico 11.243 12.1 1,393 14.5
3. China 5.455 5.9 697 7.3
4. Thailand 3.748 4.0 254 2.6
5. Indonesia 3.721 4.0 410 4.3
6. Italy 3.304 3.6 277 2.9
7. Chile 2.954 3.2 35 0.4
8. Brazil 2.701 2.9 57 0.6
9. Australia 2.477 2.7 25 0.3
10. Ireland 2.392 2.6 1 *
11. France 2.392 2.6 145 1.5
12. Netherlands 2.196 2.4 23 0.2
13. Malaysia 1.911 2.1 69 0.7
14. New Zealand 1.867 2.0 10 0.1
15. India 1.762 1.9 1,052 11.0
16. Colombia 1.757 1.9 60 0.6
17. Vietnam 1.456 1.6 353 3.7
18. Ecuador 1.338 1.4 17 0.2
19. Germany 1.284 1.4 19 0.2
20. Costa Rica 1.278 1.4 15 0.2
21. Guatemala 1.276 1.4 156 1.6
22. Argentina 1.261 1.4 20 0.2
23. Spain 1.228 1.3 94 1.0
24. Philippines 1.158 1.2 252 2.6
25. Peru 0.868 0.9 89 0.9
World Total 93.0379 100.0 9,600 100.00
Source: Prepared by CRS based on FAS BICO Import Commodity Aggregations (first three columns) and FDA
OASIS data (last two columns). A line is all or part of a shipment of no uniform size, so care should be used in
attempting any comparisons between countries, or between a country’s import value and its number of refused
lines. Asterisk (*) denotes less than one-tenth of one percent.
By industry, vegetables/vegetable products and seafood products appear to have been the most
frequently refused products from all countries generally. Fruits/fruit products from all countries
accounted for the next highest number of refusals, followed by candy products, and then
spices/flavors/salts. Many refused fruit and vegetable products originated in the Dominican
Republic, Mexico, or other Latin American and Caribbean nations; a frequently cited reason was
pesticides. Bacterial contamination (e.g., Salmonella) or filthy condition was cited numerous
times. Fish and shellfish were refused for a variety of reasons, often for bacteria, filthy condition,
and/or veterinary drug residues. These products most frequently appear to have originated in
Asian countries, not only China but also Vietnam, India, Bangladesh, and others.
A 2007 report by Food and Water Watch analyzed the FDA OASIS refusals of seafood in more
detail, and for all calendar years from 2002 to 2006. Among its findings were that more than 70%
of all imported seafood products were processed. More than 20% of all seafood refusals were due
to Salmonella, of which 40% were shrimp. It also observed that more seafood is being refused for 24
veterinary drug residues.
Many refusals of all food types also appear to be due to concerns about mislabeling, failure to
register, or failure to document that the product complied with safe manufacturing practices (e.g.,
using a system of hazard analysis and critical control points, or HACCP, for low acid canned
foods or seafoods).
A more extensive study of the OASIS data was published in September 2008 by USDA’s 25
Economic Research Service (ERS). ERS examined seven years of FDA refusals of food import
shipments, by industry group and by type of violation, which totaled 70,369 violations. Because
of differing time periods, and somewhat differing methods of counting and classifying OASIS-
reported refusals, the CRS and ERS findings are not directly comparable, but do appear to reach
parallel conclusions. Also, the ERS study did not classify refusals by country.
The ERS study found that more than half of all food safety or other violations of FDA law during
the seven-year period were among three food categories: vegetables and vegetable products
(20.6% of total violations), fishery and seafood products (20.1%), and fruits and fruit products
(11.7%). The most common violations were unsafe pesticides for vegetables and vegetable
products, filth (unsanitary) for both fishery and seafood products and fruits and fruit products, and
unregistered processes for canned foods from all three categories.
Overall, misbranding or lack of appropriate labeling accounted for 33% of the 70,369 violations,
and adulteration or safety and packaging integrity violations for 65%. “Adulteration violations
pose a wide range of food safety risks, from less severe risks, such as an insect in cooked soup, to
immediate risks to human health, like botulism in canned food. The data indicate that the most
common adulteration violations were for the appearance of filth in a food product and failure to 26
file information or register a specified process.”
Although the study revealed recurring problems in certain types of imported foods, it did “not
indicate the actual level or distribution of food safety risk ... because FDA’s process for selecting
shipments for inspection or other administrative actions is not random,” the authors wrote. “In
24 Food and Water Watch, Import Alert: Government Fails Consumers, Falls Short on Seafood Inspections, May 2007.
Last accessed on the Internet on April 16, 2008, at http://www.foodandwaterwatch.org/press/publications/reports/
25 Buzby, Jean C., Laurian J. Unnevehr, and Donna Roberts, Food Safety and Imports: An Analysis of FDA Food-
Related Import Refusal Reports (EIB-39), USDA, ERS, September 2008.
26 Food Safety and Imports: An Analysis of FDA Food-Related Import Refusal Reports, pp. iii-iv. The report contains
tables and accompanying discussion breaking out these violations in greater detail.
essence, import refusals highlight food safety problems that appear to recur in trade and where the 27
FDA has focused its import alerts and monitoring efforts.”
FSIS makes available through its website quarterly enforcement reports summarizing the actions
it has taken to ensure that unsafe, unwholesome, and improperly labeled products do not reach
consumers. Table 4 shows the total volume of meat and poultry products presented for import
reinspection and how much was refused entry into the country for several recent fiscal years—
approximately one-third of one percent of total shipments.
Table 4. Imported Meat and Poultry Products Presented for Inspection and Refused
Entry, Selected Years
(thousands of pounds)
Fiscal Year Presented Refused Entry Pct. Refused
2005 4,303,345 14,081 0.33
2006 3,888,188 12,312 0.32
2007 3,897,098 9,207 0.24
Source: USDA/FSIS, various Quarterly Enforcement Reports, accessed December 2, 2008 at
Note: The figures are based on an entirely different database and inspection regimen than the figures for FDA in
Table 2 and therefore are not comparable.
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. The following are among the major food-related developments.
In early 2007 pet food ingredients from China that contained the chemical melamine—apparently
added to boost the ingredients’ protein readings—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. However, melamine again surfaced in a number of Chinese-sourced human foods in
27 Food Safety and Imports: An Analysis of FDA Food-Related Import Refusal Reports, p. iii.
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. One month later, on June 28, 2007, FDA issued an import alert ordering the
“Detention Without Physical Examination” of all of the following aquacultured products from 28
China: catfish, basa (related to catfish), shrimp, dace (related to carp), and eel. 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
(antibiotics) 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 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
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 observed: “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.”
On November 12, 2008, FDA issued a “Detention Without Physical Examination” alert for all
milk products, milk-derived ingredients, and finished food products containing milk if they are 29
from China. In the alert, FDA stated that these products could be contaminated by melamine
and/or melamine analogs. The substance 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.
The FDA explained that in September 2008, it had become aware of reports that more than
53,000 infants had been sickened, including 13,000 who were hospitalized and four who had
died, due to consumption of infant formula containing melamine. Milk used in the formula has
been implicated as the source of the melamine, added to watered-down bulk milk at collection
points in China to inflate the protein content. However, the problem is not limited to infant
formula products; Chinese government sources also indicated that contaminated milk
28 FDA Import Alert #16-13, accessed December 1, 2008 at http://www.fda.gov/ora//fiars/ora_import_ia16131.html. A
November 21, 2008, attachment to the alert names 10 firms with various products which have since been exempted
from the detention requirement.
29 FDA Import Alert #99-30, accessed December 1, 2008, at http://www.fda.gov/ora/fiars/ora_import_ia9930.html.
components, especially milk powder, were used in a variety of finished foods dispersed 30
throughout the Chinese food supply chain.
In early December 2008, Chinese authorities reportedly issued revised estimates indicating that
six infants had died and nearly 300,000 been sickened after consuming melamine-tainted milk
products. It was reported that 860 babies remained hospitalized with kidney or urinary-tract 31
problems, 154 of them in serious condition.
More than a dozen countries throughout Asia and Europe, along with Australia and the United
States, have detected contamination of milk-derived ingredients and products with melamine and
a related contaminant. These have included candy and beverages, found here by the FDA; in
other countries, melamine has been detected in Chinese-sourced fluid and powdered milk, yogurt,
frozen desserts, biscuits, cakes and cookies, soft candy products, chocolates, and beverages.
These are the types of products included in the FDA import alert. To be released from detention,
any of these shipments must obtain independent (third-party) laboratory results that they do not
contain melamine or cyanuric acid, or have documentation that they do not contain milk or milk-
derived ingredients, according to the FDA notice. A firm importing such products can request
exemption from these testing and documentation requirements—which can greatly slow if not
completely stop its imports—by demonstrating that it has adequate safety controls in place and
that it has five consecutive non-violative shipments.
The import alert follows an earlier health information advisory issued on September 12, 2008,
where the 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 32
importing formula or sourcing milk-based materials from China.
Nonetheless, China has been exporting dairy proteins and other products to the United States for
some time, but at somewhat low levels, according to USDA trade data. 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 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 33
powders, power bars and other forms of sports and medical nutrition applications.
31 Various trade news reports, citing figures from a Chinese Ministry of Health statement.
32 On November 26, 2008, the Associated Press (AP) reported that the FDA had found traces of melamine in samples
of U.S. infant formula. Officials reportedly told the AP that the trace amounts had occurred during manufacturing, not
intentionally, and posed no health concerns. “To date, FDA tests have found extremely low levels of melamine in one
infant formula sample and extremely low levels of cyanuric acid in another,” the FDA subsequently announced on a
web page, “Melamine Contamination in China,” accessed December 1, 2008. “The levels were so low (well below 1
ppm) that they do not pose a health risk to infants.” The FDA based this observation on an update of an earlier (October
2008) health risk assessment which had previously stated that it “cannot establish a level of melamine and its analogues
in these products that does not raise public health concerns.” The FDA web page, accessed on December 1, 2008, also
contains links to both health assessments. See http://www.fda.gov/oc/opacom/hottopics/melamine.html.
33 U.S. International Trade Commission, Conditions of Competition for Milk Protein Products in the U.S. Market
(Investigation No. 332—453), May 2004.
China has faced a number of food safety challenges as it becomes a major food and agricultural
exporter. USDA economists had written 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 slowed when shipments of
vegetables, poultry and shrimp were rejected for failing to meet stringent standards in Japan,
Europe, and other countries, revealing a gap between Chinese and international food safety 34
Some analysts have contended 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:
• highly decentralized farm production, composed of 200 million households
typically farming on plots of one to two noncontiguous acres;
• 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;
• 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
• 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 which
handle small volumes, often on a cash basis with no documentation or ability to
• 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 35
standards that are inconsistent with internationally accepted ones.
34 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
35 Calvin. Also, Fengxia Dong and Helen H. Jensen, “Challenges for China’s Agricultural Exports: Compliance with
Sanitary and Phytosanitary Measures,” Choices, 1st quarter 2007.
A 2008 report published by the Woodrow Wilson International Center for Scholars summarized
China’s capacity to effectively protect food quality is hampered by a weak legal, political,
and regulatory infrastructure that has not forced food producers and processors to be
accountable. Key weaknesses in China’s food safety governance system include: strong local
government protectionism of industries; a lack of product liability law; and weak monitoring
capacity of food products, due both to vast numbers of small-scale food producers and
processors and competition among regulating agencies. China also lacks an independent
court system, which could better protect consumers and company whistleblowers. Consumer 36
education is also lagging, in part due to few consumer watchdog organizations.
The authors noted that contaminated Chinese food exports tend to be linked to unsafe use of 37
chemicals, including high pesticide use, and illegal veterinary drugs in aquaculture.
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 exports (including food and toys). However, the Ministry of Health and the 38
SFDA have “minimal” roles in regulating exports.
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 39
establishments. According to another expert, China officially has 448,000 food enterprises, 78% 40
of them “cottage industries” with 10 employees or fewer.
The Chinese government says it has launched a series of major initiatives to bolster food safety
programs (see below), notwithstanding its continuing assertions that its products are safe. Chinese
officials also declared in 2007 that U.S. importing companies need to look beyond their emphasis 41
on low prices and communicate more clearly what their standards are. In September 2007, a
36 Ellis, Linden J., and Jennifer L. Turner, Sowing the Seeds: Opportunities for U.S.-China Cooperation on Food Safety
(excerpt from Executive Summary), Woodrow Wilson International Center for Scholars, China Environment Forum,
38 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.”
39 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.
40 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
41 “U.S., Chinese leaders try to advance trade, food safety issues,” Agri-Pulse, May 30, 2007.
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 States to check 42
on whether Chinese exporters had been approved by the Chinese government.
Bush Administration officials attempted to reassure Congress throughout 2007 and 2008 that they
have been 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
The Chinese joined U.S. officials from the Department of Health and Human Services (HHS) in
announcing, on December 11, 2007, a memorandum of agreement (MOA) to enhance the safety
of food and feed imports from China (and, conversely, U.S. exports to 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 43
(APEC) ministerial in Sydney, Australia. 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 44
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.
Progress in implementing the agreement appears to be slow. In a December 2008 progress report
on its food safety strategy generally (see “Bush Administration Initiatives,” later in this report),
FDA stated that it has met its first set of deadlines by providing registration materials to the
42 See for example: “Senior Chinese Official Hopes Chinese Actions Will Delay Legislation,” FDA Week, September
43 Also announced on December 11, 2007, was a second bilateral agreement on drugs and medical devices.
44 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, last accessed April 16, 2008, at http://globalhealth.gov/news/agreements/ia121107b.html.
Chinese government, identifying points of contact for the MOA, and drafting the first 12-month
plan. It also described a March 2008 meeting with Chinese officials in Beijing, where there was
“verbal agreement to limit the present efforts in fulfilling the MOA to aquaculture (five species 45
plus tilapia) and ingredients (wheat gluten, corn gluten and rice protein).”
Stakeholders earlier had 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 oversight and
enforcement; and whether the agency has the appropriate legal authority to share information 46
about U.S. food companies or to demand certificates from foreign importers.
China has cited numerous efforts underway to improve confidence in the safety of its food (and
drug) exports, and reassure its own consumers. One prominent example is development of a new
food safety law, a draft of which was presented to a committee of the National People’s Congress
in December 2007. A revised draft circulating in 2008 proposes the creation of an agency under
the Department of Health, use of an expert panel of scientists and stakeholders, and development
of a national risk assessment system. Food additives would be more stringently regulated. Among
other things, the draft would make local governments responsible for oversight of national
standards, substantially increase penalties for violators, establish a “blacklist” for both exporters
and domestic importers who distribute unqualified food products, and include recall provisions. 47
The Chinese legislature reportedly began to review the draft law in October 2008.
Other widely reported announcements have included the following:
• Reform of the entire Chinese dairy industry was announced in late November
2008 following the melamine scandal. It is to include revised product quality and
safety standards, new examination procedures to test for melamine and other
contaminants, a dairy product tracking system, and more regulation at raw milk 48
• Planned spending of $73 million to enhance food safety surveillance was 49
45 FDA, “Food Protection Plan: Once-year Progress Summary,” December 2008.
46 See for example: “U.S.-China Food Safety Deal Could Give China Preferential Treatment,” FDA Week, December
47 Sources: various 2008 news reports; also, USDA, FAS, Food Safety Top Priority, GAIN report CH8016, March 14,
2008; USDA, FAS, Agricultural Situation News Flash I.28, GAIN report CH7065, August 10, 2007; and Xinhua
Financial Network News, “China again vows to beef up product quality and safety standards, March 6, 2008. A
translation of the April 20, 2008 version of the plan was accessed December 2, 2008 at http://www.wilsoncenter.org/
48 AP, “China to overhaul battered dairy industry,” November 20, 2008.
49 China Daily, “CHINA: $73 million to beef up food safety surveillance,” November 19, 2008.
• A death sentence was handed down to the former head of the government’s food
and drug safety agency, who was convicted of taking bribes for approving 50
potentially dangerous drugs. He reportedly was executed on July 10, 2007.
• 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
• According to U.S. agricultural attache reports, China’s AQSIQ announced that it
would begin affixing inspection and quarantine labels to all food product 51
packages for export after inspection, effective September 1, 2007.
• On August 20, 2007, the Chinese government announced that it had created a 19-
member cabinet-level panel to oversee product quality and food safety and would
start a four-month nationwide campaign to improve the quality of goods and 52
The Bush Administration had released, on November 6, 2007, two separate but related reports on
how it wanted to improve food import safety. The broader of the two covered the safety of most
imports for consumers, including but not limited to food. This Action Plan for Import Safety was 53
prepared for the President by the Interagency Working Group on Import Safety. The other report
is FDA’s Food Protection Plan, which focused on food, whether imported or domestically
produced, and which contained recommendations for food imports that generally parallel those in 54
the broader report.
Both plans were oriented toward assessing and prioritizing risks regardless of where they occur
(starting with a product’s origin), and preventing rather than waiting for problems to occur. Both
plans appeared to rely heavily on cooperation with others, including private industry stakeholders
and foreign governments, to assure safety, but they also would require some new regulations and,
in a number of areas, new legislative authorities, which would affect importers as well as others
in the food system.
50 See for example: “China Executes Former Head of Food Safety Agency,” Wall Street Journal, July 10, 2007.
51 For details of the change see USDA, FAS, China to attach inspection and quarantine labels for food exports, GAIN
report CH7059, July 23, 2007.
52 See also CRS Report RS22713, Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview,
by Wayne M. Morrison.
53 Accessed April 16, 2008, at http://www.importsafety.gov/report/actionplan.pdf.
54 Accessed April 16, 2008, at http://www.fda.gov/oc/initiatives/advance/food/plan.html.
The FDA report observed that the type of imported foods has been changing, from largely
unprocessed bulk ingredients for subsequent processing by domestic establishments, to more
ready-to-eat products, fresh produce, and seafood. “This is not to suggest that food imported into
the United States, as a whole, poses a greater food safety risk than domestically produced food.
But increases in the volume and complexity of imported foods have taxed the limits of FDA’s
approach to handing imports,” the report stated, adding that the agency often has “very limited
information regarding conditions under which most food is produced in foreign countries.” Some
countries have well-developed food safety systems, while others may not, it concluded.
It was unclear in December 2008 what elements of the plans an Obama-led FDA might continue
to pursue and/or build upon. Critics, among them the Government Accountability Office (GAO),
consumer organizations, and the chair of the House Appropriations Subcommittee on Agriculture,
have complained that the Bush Administration failed to provide enough details on the various
initiatives, including their costs and how they intended to implement them. Some criticized both
the food safety and import plans as largely a collection of objectives, lacking resources and/or
enforcement controls to be effective, or otherwise inadequate.
The FDA released, in early December 2008, a one-year progress report on its plan, taking note of
a number of accomplishments, including the establishment of the first overseas offices—three in 55
China in November 2008. The FDA also intends to open permanent offices in other foreign
countries throughout the world, as part of an effort to build and maintain relationships with
regulators and companies in those countries, and to discourage their export of substandard foods 56
and drugs in the first place.
Consumer advocacy organizations expressed skepticism about FDA’s progress and again
challenged the basic plan itself, which, they asserted, does not fundamentally change a flawed
U.S. food safety system. Specifically, they questioned the potential impacts of opening offices in
China and other countries. Suggesting that the offices “might be window dressing,” one consumer
advocate expressed uncertainty about whether China will cooperate with U.S. officials there. A
food safety expert indicated that to be more effective, those officials should be skilled at, and 57
tasked with, conducting inspections, for example.
Pending at the close of the 110th Congress were at least a dozen major food safety bills which
contained provisions addressing some aspect of food import safety. One (H.R. 3580) was enacted
as P.L. 110-85; see below. Several of the pending bills focused almost exclusively on the import
issue. Also being circulated widely in spring and summer of 2008 were separate draft bills by
55 FDA, “Food Protection Plan: Once-year Progress Summary,” December 2008. At the same time the offices were
formally opened, China announced that it intended to establish its own food safety offices in the United States, to be
staffed by AQSIQ and State Food and Drug Administration officials.
56 Various sources including “FDA Plans to Put 8 People in China; Next Up: India, South America, Middle East,”
Inside Health Policy, March 17, 2008; World Trade Daily, April 14, 2008; and “State Department Allows FDA to
Place Eight Staffers in China,” Congress Daily P.M., March 13, 2008.
57 Sources: Various news sources, including Food Chemical News, InsideHealthPolicy.com, and Congress Daily.
Chairman Kennedy of the Senate Health, Education, Labor, and Pensions Committee and
Chairman Dingell of the House Energy and Commerce Committee; these were broad FDA food
and drug safety proposals with significant import-related provisions. Another broad bill focusing
on food safety, with a separate import title, was S. 3385, introduced July 31, 2008, by Senator
Among other relevant panels are the House and Senate Agriculture Committees, where USDA-
related food safety bills are referred, and the Appropriations Committees, which recommend the
annual funding for such initiatives.
If and when these or similar bills are introduced into the 111th Congress, they could become the
chief vehicles for the next round of food safety legislation—which is widely anticipated to begin
in the first session. The following selected issues and options are expected to continue as topics of th
debate in the coming year. (Bill numbers cited here are from the 110 Congress.)
One oft-proposed legislative option which would have affected importers directly was specific
authorization for FDA to require import certificates for shippers and/or shipments of products,
prior to their arrival in the United States. FDA’s current statute does not expressly offer this
authority. The Bush Administration’s plan, for example, called for electronic certificates for
products deemed to be of high risk, i.e., those products “that have been shown to pose a threat to
public health for U.S. consumers and thus would be unlike other imports where there is no such
showing of risk.” For such products, FDA would have to negotiate and implement government-
to-government agreements whereby an importer would obtain certificates from either the
appropriate foreign agency or an accredited third party. This new certification system, which
appeared to be based at least in part on the concept of the FSIS foreign equivalency
determinations, presumably would have to be consistent with international trade obligations.
The Kennedy draft bill would have authorized (but not required) the HHS Secretary to require an
electronic certification by the “competent regulatory authority” of the exporting country that a
food shipment entering the United States meets FDA food safety standards. HHS would have
been required to notify the Secretary of Homeland Security of any such requirement, who in turn
must deny the importation of an item that lacks certification. The Dingell draft would have
required the HHS Secretary to establish a program for accreditation of foreign governments, state
or regional food authorities, foreign or domestic cooperatives, or other appropriate third parties to
certify food facilities. Under the certification program, which could be limited to specific food
types, HHS (i.e., FDA) would first have to evaluate the foreign government’s food safety system,
among other Dingell provisions. The Durbin bill (S. 3385) contained authority for the Secretary
to require certifications, from qualified entities, for foods deemed to be of high risk from
countries with which FDA has an agreement for such a program. Foods that require such a
certificate but lack it would have been denied import entry under S. 3385.
A number of other food safety bills also proposed 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 have been denied or revoked if
foreign safeguards are found to be insufficient, unsafe imports are discovered, or foodborne
illnesses are linked to such products.
FDA generally has access to domestic food facilities because it can obtain a warrant or initiate
criminal proceedings if it is denied entry—authorities it lacks for overseas establishments. Some
including the Bush Administration proposed that to “provide parity” between domestic and
imported foods, authority should be enacted enabling FDA to block imports of foods by foreign
firms that impede entry to their facilities that produce, process, or hold such foods. S. 3385, for
example, would have authorized the Secretary to enter into agreements with other governments
that would enable such inspections; imports from facilities that impede such inspections would be
The Bush FDA requested mandatory recall authority in cases where firms (whether foreign or
domestic) are unwilling to do so voluntarily or expeditiously. The agency noted that it already has
the authority to seize adulterated or misbranded food, but that may not be practical once a product
is in wide distribution. The agency also was seeking authority to give it more access to records in
cases of food emergencies. Significantly, a major food industry group, the Grocery Manufacturers 58
Association (GMA), endorsed the proposal for mandatory recall authority. The day after the
Bush Administration proposed it for FDA, a USDA official asserted that the Department does not
need similar mandatory recall authority for the meat and poultry products it regulates.
Responding to questions on whether he would request such authority, he stated that USDA
already has sufficient enforcement tools and that the voluntary approach now in place works 59
well. Others, however, continue to seek it for USDA-regulated foods, and several bills in the th60
110 Congress reflected this proposed change. The Dingell and Kennedy drafts both contained
authority for FDA to require a recall if a person or firm fails to do so voluntarily, although the
details of this authority differed among the bills.
Some bills sought to require more physical inspections and testing at the border or within other
countries, and to authorize more research into inspection and testing technologies. Some wanted
FDA or another public health agency to undertake more of these activities. However, some
proposals, including the Bush Administration’s, sought authority for FDA accreditation of
qualified third parties to conduct some types of inspections and testing. Both the Dingell and
Kennedy drafts also involved third-party certification for certain types of inspection and/or
testing, as did S. 3385. Conceptually under a third-party approach, FDA might officially certify
qualified private companies, professional organizations, or governmental agencies (whether
foreign, state, or local), which importers could in turn use (and presumably pay a service fee) to
certify the safety of their products using prescribed tests, inspection regimes, or other FDA-issued
criteria. According to proponents, so-called third-party accreditation could help to address FDA
58 “GMA Applauds Bush Administration’s Focus on Prevention in Effort to Improve Safety of Imported Food,”
November 6, 2007, press release, at http://www.gmaonline.org/news/docs/NewsRelease.cfm?DocID=1806&.
59 Dr. Richard Raymond, Undersecretary for Food Safety, November 7, 2007, testimony before the House Agriculture
Subcommittee on Livestock, Dairy, and Poultry.
60 See also CRS Report RL34167, The FDA’s Authority to Recall Products, by Vanessa K. Burrows, and CRS Report
RL34313, The USDA’s Authority to Recall Meat and Poultry Products, by Cynthia Brougher and Geoffrey S. Becker.
staffing and funding limitations. Certifying third parties also could deter errant importers from
testing their own products—or from “shopping for” private laboratories—to obtain more 61
acceptable results, these proponents argue. Many consumer advocates are skeptical of more
third-party responsibility, arguing that it can weaken government oversight of public health.
Most policymakers concede that regardless of the policy approach adopted, additional resources
are needed to adequately address import safety problems. According to a report released in early
December 2007 by the FDA Science Board, the FDA Commissioner’s expert advisory panel, a
critical lack of resources has seriously weakened the FDA’s scientific basis generally and its
mission to protect the food supply particularly. The panel noted that the FDA was unable to
“sufficiently monitor either the tremendous volume of products manufactured domestically or the
exponential growth of imported products. During the past 35 years, the decrease in FDA funding
for inspection of our food supply has forced FDA to impose a 78 percent reduction in food
inspections, at a time when the food industry has been rapidly expanding and food importation
has exponentially increased.” As noted, the Science Board recommended that the overall FDA
appropriation (not just for food) be more than doubled over the next several years from its 62
FY2008 level of approximately $1.5 billion, exclusive of user fees.
FDA and FSIS receive most of their funding through the annual Agriculture, Rural Development,
Food and Drug Administration, and Related Agencies Appropriations Act. However, requests for
higher appropriations must compete with other priorities throughout the federal discretionary
budget. An alternative, to fill perceived shortfalls through new user fees on the food industry,
always meets with resistance, both from the companies that would have to absorb such costs and
from consumer advocates, who have long argued that industry funds might “taint” programs that 63
are first and foremost public health programs.
Nonetheless, a number of food safety bills have included proposed user or other types of fees to
pay for such new activities as certification of food imports, re-inspection of products initially kept
out of commerce, and the auditing of private food testing laboratories. For example, the Dingell
draft would have required importers of food, drugs, and other FDA-regulated products to register
and pay an annual fee of $10,000. The Kennedy draft also would have provided for various
registration and certification fees.
Among other proposed statutory changes that would affect importers and domestic firms alike
have been authority for regulations that would require food chain entities to implement measures
61 See for example: “Lab Chief Tells Lawmakers Importers Can Hide Food Contamination Data From FDA,” Inside
Health Policy, February 26, 2008.
62 FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, prepared for the FDA
Science Board, November 2007. See also CRS Report RL34334, The Food and Drug Administration: Budget and
Statutory History, FY1980-FY2007, by Judith A. Johnson et al.
63 FDA received additional funding, including for its food safety activities generally, as part of the FY2008
supplemental appropriation (P.L. 110-252); this increased level was continued by the Consolidated Security, Disaster
Assistance, and Continuing Appropriations Act, 2009 (P.L. 110-329). For more information see CRS Report RL34638,
FDA FY2009 Appropriations, by Susan Thaul et al.
solely intended to prevent intentional food adulteration by terrorists or criminals; more explicit
authority to require additional preventive (HACCP-like) controls for high-risk foods (authority
some believe FDA already has); restriction of food and drug imports to specific ports with FDA
labs for testing; authority to require facilities to renew their currently required FDA registrations
every two years, to establish food categories within this system, and to deny re-registration to
those who violate food safety rules; and more extensive mandatory country of origin labeling 64
(COOL), so that consumers can determine where food products and their ingredients originate.
Geoffrey S. Becker
Specialist in Agricultural Policy
64 This report does not cover COOL proposals. See CRS Report RS22955, Country-of-Origin Labeling for Foods, by
Geoffrey S. Becker.