The USDA's Authority to Recall Meat and Poultry Products

The USDA’s Authority to Recall
Meat and Poultry Products
Updated August 13, 2008
Cynthia Brougher
Legislative Attorney
American Law Division
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science, and Industry Division

The USDA’s Authority to Recall
Meat and Poultry Products
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection
Service (FSIS) has monitored numerous recalls of meat and poultry products sold in
the United States. The recalls have involved beef products possibly contaminated
with E. coli O157:H7, beef and poultry products possibly contaminated with
Salmonella, and canned meat products possibly contaminated by botulism. These
recalls raise issues of consumer confidence in the meat industry and questions about
the adequacy of the USDA oversight of these products.
The issue received new attention in February 2008, when USDA announced the
largest-ever recall, of 143.4 million pounds of fresh and frozen beef products from
a California slaughterer-processor. The Class II recall (meaning only a remote
possibility of adverse health effects) was in response to evidence that nonambulatory
(“downer”) cattle had been mistreated and periodically slaughtered for food, in
violation of a federal humane slaughter law and of meat safety regulations,
Following these recalls, Congress included in the 2008 farm law (P.L. 110-246)
new requirements for establishments to promptly notify USDA about potentially
adulterated or mislabeled meat and poultry products and also to develop and maintain
plans for conducting a recall. Other issues that remain for Congress to consider are
whether USDA should be given mandatory recall authority; whether notification
and/or recall planning rules should be more prescriptive; and whether new
recordkeeping and product traceability requirements are needed.
Currently, USDA does not have authority to mandate a recall of meat and
poultry products. Rather, USDA, through FSIS, monitors food companies’ recalls.
When FSIS learns of a potential recall, it convenes a recall committee, which makes
recommendations based on information such as any pertinent production and
distribution data provided by the company. Once the company initiates a recall, FSIS
immediately issues a press release to notify the public, posts it on its website, and
provides information directly to stakeholders — including Congress, the media,
federal, state, and local officials, and constituents — via e-mail and faxes. At the
conclusion of the recall, FSIS conducts an effectiveness check to determine whether
all appropriate parties were properly notified and all reasonable efforts were made to
retrieve, destroy, or return the recalled product to the firm.
This report provides an overview of the USDA’s authority to regulate meat,
poultry, and their products. Specifically, it discusses the requirements of USDA
inspections and import regulations, as well as the USDA’s role in product recalls.
This report also addresses some of the issues that arise when considering possible
changes to recall authority and reviews proposed legislation regarding the role of the
USDA in the recall process. The Appendix of this report provides information
regarding recent recalls and the significance of the recall data.

Background ..................................................1
Current Statutory Authority to Regulate Meat and Poultry Products......2
Authority to Regulate Imports................................3
Inspection Authority.......................................3
Current USDA Regulations and Guidance Regarding Recalls...........4
Industry-Initiated Recalls....................................5
Recall Recommendations....................................5
Recall Classifications.......................................6
Extent of Recall...........................................6
Communication Regarding Recalls............................7
Monitoring and Termination of Recalls.........................8
Selected Issues and Bills........................................9
Is Mandatory Authority Needed?..............................9
Responsibility Questions...................................10
Notification Requirements..................................11
Traceability .............................................11
Recovery Rates and Recall Effectiveness......................12
Significance of Recall Data.................................13
Appendix. Information Regarding Meat and Poultry Product Recalls........15
Recent Recalls...............................................15
Recall 005-2008, Beef Products.............................18
Recall 040-2007, Ground Beef Products.......................19
Recall 055-2002, Beef Trim and Fresh and Frozen
Ground Beef Products.................................20
Recall 090-2002, Turkey and Chicken Products.................20
Recall 015-1997, Frozen Ground Beef Patties...................21
List of Figures
Figure 1. FSIS Meat and Poultry Recalls, January 1994-November 2007.....16
Figure 2. FSIS Meat and Poultry Recalls, January 1994-November 2007.....16
Figure 3. Recalls by Reason, January 1994-November 2007...............17
Figure 4. Recalls by Product Type, January 1994-November 2007..........17
List of Tables
Table 1. Largest Recalls Since 1994..................................18

The USDA’s Authority to Recall
Meat and Poultry Products
The Food Safety and Inspection Service (FSIS) within the U.S. Department of
Agriculture (USDA) has monitored numerous recalls of meat and poultry products
sold in the United States.1 The recalls have involved beef products possibly
contaminated with E. coli O157:H7, beef and poultry products possibly contaminated
with Salmonella, and canned meat products possibly contaminated by botulism. A
recall is “a firm’s voluntary removal of distributed meat or poultry products from
commerce when there is reason to believe that such products are adulterated or2
Recalls were again in the news in February 2008, when USDA announced the
largest-ever recall — 143.4 million pounds of fresh and frozen beef products from
a California slaughterer-processor. The Class II recall was in response to evidence
that nonambulatory (“downer”) cattle had been mistreated and periodically
slaughtered for food, in violation of a federal humane slaughter law and of meat
safety regulations, respectively. (See “Recall Classifications,” below, for a definition
of Class II.)
Recalls raise issues of consumer confidence in the meat industry and questions
of the adequacy of the USDA oversight. A 2004 Government Accountability Office
(GAO) report criticized the adequacy of efforts to monitor and ensure compliance

1 The FSIS has authority to regulate the safety and proper labeling of most meat, poultry,
and their products and of some egg products. The Food and Drug Administration (FDA),
within the Department of Health and Human Services, is responsible for the safety of all
other foods. For a broader overview of issues relating to USDA’s role in meat and poultry
regulation, see CRS Report RL32922, Meat and Poultry Inspection: Background and
Selected Issues, by Geoffrey S. Becker. For information on federal authority to regulate
other food products, see CRS Report RL34167, The FDA’s Authority to Recall Products,
by Vanessa K. Burrows. For more information on food safety issues generally, see CRS
Report RS22600, The Federal Food Safety System: A Primer, by Geoffrey S. Becker and
Donna V. Porter.
2 Recall of Meat and Poultry Products, FSIS Directive 8080.1, Revision 4, May 24, 2004,
part VI, available at [
pdf]. FSIS does not include market withdrawals or stock recoveries in the definition of
recall. A market withdrawal is “a firm’s removal or correction on its own volition of a
distributed product that involves a minor infraction that would not warrant legal action by
FSIS and constitutes no health hazard.” Id. A stock recovery is “a firm’s removal or
correction of a product that has not been marketed or that has not left the direct control of
the firm.” Id.

with recalls, noting that “concerns that contaminated food could reach consumers
have also intensified because of the potential susceptibility of food to deliberate
Although recalls are voluntary, USDA may withhold products from the food
supply through its regulation of imports, its inspection and approval process, and its
power to seize and detain products that are in violation of its regulations.4 This
report provides an overview of the USDA’s statutory authority to regulate meat,
poultry, and their products. Specifically, the report discusses the requirements of
USDA relating to inspections and import regulations, as well as the USDA’s role in
product recalls, including its power to seize and detain products in commerce. This
report also addresses issues surrounding the debate over expansion of USDA
authority to require recalls of products known or suspected to be adulterated and
legislative proposals to change the current recall process. Information about recent
recalls and analysis of recall data can be found in the Appendix of the report.
Current Statutory Authority to Regulate
Meat and Poultry Products
The USDA does not currently have statutory authority to issue mandatory recalls
of contaminated products. Recalls, which withdraw products from the food supply,
must be voluntarily initiated by a manufacturer or distributor, and these entities
generally bear the cost of any recall. The USDA does have statutory authority to
perform other regulatory functions involving meat and poultry under the Federal
Meat Inspection Act (FMIA)5 and the Poultry Products Inspection Act (PPIA),67
These acts authorize the USDA to regulate the safety, wholesomeness, and
proper labeling of domestic and imported meat, poultry, and their products sold for
human consumption. USDA has assigned its authority to FSIS, which carries out
USDA’s authority under the acts.8 Though FSIS may not mandate recalls, it can keep

3 Government Accountability Office, Food Safety: USDA and FDA Need to Better Ensure
Prompt and Complete Recalls of Potentially Unsafe Food (October 2004), [http://www.gao.
gov/ new.items /d0551.pdf].
4 For general information about FSIS recalls and links to various agency resources, see FSIS
Food Recalls Fact Sheet, available at [
5 21 U.S.C. § 601 et seq.
6 21 U.S.C. § 451 et seq.
7 The USDA also has authority to regulate egg products under the Egg Products Inspection
Act (EPIA). 21 U.S.C. § 1031 et seq. The USDA shares this authority with the FDA. The
statutory provisions governing regulation of imports and inspection of egg products that fall
under the jurisdiction of the USDA are similar to the provisions relating to meat, poultry,
and their products. However, because USDA does not have exclusive authority to regulate
eggs, this report does not address these provisions.
8 The Secretary delegates this authority to FSIS under 9 C.F.R. § 300.2.

some products from entering the food supply through its role in importation
regulation and inspections.
Authority to Regulate Imports. Meat, poultry, and their products may not
be imported if they do not comport with the standards provided by U.S. law. FMIA
prohibits importation of any carcasses, meat or meat food products that are meant for910
human consumption if they are adulterated, misbranded, or do not comply with
other inspection and facilities standards provided in the act.11 PPIA prohibits
importation of “slaughtered poultry, or parts or products thereof” if they are not
healthful, wholesome, unadulterated or fit for human consumption or if they do not12
comply with the standards provided in the act.
Imported items must comply with U.S. domestic sanitary protection standards.
Specifically, poultry imports must be “subject to inspection, sanitary, quality, species
verification, and residue standards” and must have been “processed in facilities and
under conditions that achieve a level of sanitary protection equivalent to that13
achieved under United States standards.” Meat imports are subject to the same
standards.14 These requirements are enforceable through random inspection and15
testing of products by FSIS.
Imported items that do not comply with these requirements can be refused entry
into the United States. Items that are refused entry into the United States and not16
exported within the designated time period are subject to destruction by FSIS.
Inspection Authority. The FMIA requires FSIS to inspect all cattle, sheep,
swine, goats, horses, mules, and other equines before they enter any plant to be

9 A product can be considered “adulterated” if it “bears or contains any poisonous or
deleterious substance which may render it injurious to health”; contains any additives
considered unsafe; “consists in whole or in part of any filthy, putrid, or decomposed
substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit
for human food”; or “has been prepared, packed, or held under insanitary conditions.” See
21 U.S.C. § 601(m). In response to the Westland/Hallmark recall, H.R. 5762 proposes to
amend the definition of “adulterated” to include products derived from nonambulatory
10 A product can be considered “misbranded” if its label is false or misleading; contains an
inaccurate description of the product; does not identify manufacturer, packer, or distributor
and an accurate statement of quantity of the contents; or does not contain other information
that may be required by the act. See 21 U.S.C. § 601(n).
11 21 U.S.C. § 620(a).
12 21 U.S.C. § 466(a).
13 21 U.S.C. § 466(d).
14 21 U.S.C. § 620(f).
15 21 U.S.C. § 466(d)(4); 21 U.S.C. § 620(f).
16 See 21 U.S.C. § 620(b); 21 U.S.C. § 466(b).

slaughtered and processed for human consumption.17 The PPIA requires inspection
of any domesticated birds that might be processed for human consumption.18
These statutes provide for ante mortem and post mortem inspections. Livestock
and poultry covered under the statutes must be examined and inspected before entry
into a plant for slaughtering or processing (ante mortem inspection).19 The carcasses
must also be examined after the animals are slaughtered (post mortem inspection).20
Inspectors are responsible for inspecting the methods of slaughtering, handling, and
processing, as well as the facilities in which these activities take place.21 They also
inspect the establishment’s sanitation quality.22 In order to conduct these inspections,
inspectors must have access at all times to the entire facility in which the animals are
slaughtered or processed.23
This inspection process regulates the entry of meat and poultry products into the
food supply. If inspectors find that an establishment or animals do not meet FSIS
standards, the FSIS may cease or refuse inspection services.24 Products inspected and
approved as unadulterated must be clearly labeled before entry into the food supply.25
Products inspected and not approved must be destroyed.26
Current USDA Regulations and Guidance Regarding Recalls
While USDA has statutory authority to prevent meat and poultry products from
entering the food supply, it lacks authority to withdraw products already in the food
supply. Rather, recalls of meat and poultry products are voluntary actions taken by
food companies. USDA has long relied on this voluntary, cooperative approach
between FSIS and meat and poultry establishments. If an establishment conducts the
recall, FSIS provides assistance and monitors the recall. If an establishment does not
conduct the recall, FSIS is limited to its authority to detain and seize the products in
question. Recall policies are spelled out in FSIS Directive 8080.1.27

17 21 U.S.C. § 601 et seq.
18 21 U.S.C. § 451 et seq.
19 See 21 U.S.C. § 603; 21 U.S.C. § 455(a).
20 See 21 U.S.C. § 604; 21 U.S.C. § 455(b).
21 21 U.S.C. § 603.
22 21 U.S.C. § 608; 21 U.S.C. § 456.
23 21 U.S.C. § 606; 9 C.F.R. § 300.6.
24 21 U.S.C. § 603(b); 21 U.S.C. § 467.
25 21 U.S.C. § 606; 21 U.S.C. § 457.
26 21 U.S.C. § 604; 21 U.S.C. § 455.
27 Recall of Meat and Poultry Products, FSIS Directive 8080.1, Revision 4, May 24, 2004,
available at []
(hereinafter FSIS Directive 8080.1).

Authority for Detentions and Seizures. If a firm does not follow FSIS’
recommendation to conduct a recall, “FSIS will detain any product that would have28
been subject to a recall that it finds in commerce.” FSIS has the authority to detain
any meat or poultry product after making two determinations. First, it must find that
the product is being held for distribution, in the process of being distributed, or
already distributed in commerce.29 Second, FSIS must have reason to believe that
any such article: (a) “is adulterated or misbranded and is capable of use as human
food;” (b) “has not been inspected;” or (c) “has been or is intended to be, distributed30
in violation of [any federal or state law].”
Under these regulations, the authorized detention period cannot exceed 20
days.31 If FSIS detains a product, the agency “will issue a press release informing the
public that product that appears to be adulterated or misbranded has been shipped by
the responsible firm, and that the firm has refused to recall it.”32
Industry-Initiated Recalls. FSIS provides recall guidelines for firms that
wish to voluntarily recall a product. The guidelines suggest identifying a recall
coordinator, developing a recall plan, and issuing recall communications and
notifications.33 FSIS also notes that it “expects that, once it is determined that a
recall will be undertaken, the recalling firm will immediately notify FSIS.”34
FSIS notes that “[t]here is no regulatory requirement that an establishment
[include] this recall plan in its HACCP plan or as a prerequisite program; however,
FSIS believes that prudent establishments will.”35 HACCP (Hazard Analysis and
Critical Control Points) is the safety prevention plan that FSIS requires of every
inspected establishment.
Recall Recommendations. FSIS monitors and oversees voluntary recalls.
FSIS oversight begins when it learns of a potential recall. FSIS may learn of a
potential recall from various sources: (1) the manufacturer or distributor of the
product; (2) test results from FSIS sampling programs; (3) observations or inquiries
by FSIS inspection program personnel; (4) consumer complaints; or (5)
epidemiological data submitted by various federal, state, and local agencies.36 If a

28 FSIS Directive 8080.1, part VIII.B.
29 9 C.F.R. § 329.1.
30 Id. See also 9 C.F.R. 381.210.
31 See 9 C.F.R. 329.1; 9 C.F.R. § 381.210.
32 FSIS Directive 8080.1, part VIII.B.
33 FSIS Directive 8080.1, Attachment 1.
34 FSIS Directive 8080.1, Attachment 1, part 3.
35 FSIS Directive 8080.1, Attachment 1, part 1.
36 FSIS Directive 8080.1, part V.B.

recall may appear appropriate, FSIS assembles a Recall Committee and responds to
any threats or hazards posed by the recall.37
The Recall Committee makes a preliminary evaluation to determine whether to
recommend a recall of the product. In this evaluation, FSIS considers the nature of
the defect, the actual occurrence of any illnesses or injuries, and the likelihood and
type of illness or injury that may result.38 If FSIS issues a recall recommendation, the
recommendation will contain the following information: (1) whether the firm is
voluntarily recalling the product; (2) the reason for the recall and any reason to
believe the product is adulterated or misbranded; (3) the recall classification; (4) the
depth of the recall; (5) the scope of the recall, which “defines the amount and kind
of product in question”; (6) the ability of distributors and consumers of the product
to identify it; and (7) the estimated amount of the product in distribution.39
Recall Classifications. Recall classifications are based on the public health
risk posed by the product in question. One of three levels, or classes, of recalls can
be designated. Class I recalls are the most serious and involve “situation[s] where
there is a reasonable probability that the use of the product will cause serious, adverse40
health consequences or death.” Pathogens like Listeria monocytogenes or
Salmonella on ready-to-eat products, or E. coli O157:H7 on raw beef products are
examples of Class I recalls.
Class II recalls involve “situation[s] where there is a remote probability of
adverse health consequences from the use of the product.”41 The undisclosed
presence of a small amount of a potentially allergenic substance or the presence of
a nonsharp-edged foreign material like plastic are examples of Class II recalls. Class
III recalls involve “situation[s] where the use of the product will not cause adverse
health consequences.”42 The presence of excess water in a product might lead to a
Class III recall.
Extent of Recall. The depth of the recall identifies the level of distribution to
which the recall extends. If a recall extends to the consumer level, the recall applies
to “household consumers, as well as all other levels of distribution.”43 If the recall
extends to the retail level, the product is recalled from all retail sales.44 If it extends
to the user level, the recall applies to user entities, including “hotels, restaurants, and

37 FSIS Directive 8080.1, part VI.I.
38 FSIS Directive 8080.1, part VII.B.
39 FSIS Directive 8080.1, part VII.C.
40 FSIS Directive 8080.1, part VI.D.
41 Id.
42 Id.
43 FSIS Directive 8080.1, part VI.E.
44 Id.

other food service institutional consignees.”45 If the recall applies to the wholesale
level, it involves “the distribution level between the manufacturer and the retailer.”46
Communication Regarding Recalls. FSIS uses press releases and recall47
notification reports to inform the public of recalled products. FSIS issues press
releases for Class I or Class II recalls but generally not for Class III recalls.48 The
press release and a photo of the product are posted on FSIS’ website, and the
information is disseminated to stakeholders (including Congress), news media, and49
public health officials.
The press release includes a detailed description (and photo, if possible) of the
product, the reason it is being recalled and the risk associated with the product’s50
use. It also instructs the public about the appropriate responses to be taken after the
product is identified and provides contact information for questions.51 The press52
release also indicates the product’s destination to better alert potential consumers.
If FSIS verifies “that all products in question were removed from commerce and
brought under the firm’s control before FSIS requested a recall,” FSIS issues recall
notification reports with general information about the recall, including information
similar to recall recommendations.53 Recall notification reports are issued for all54
classes of recalls and are also posted on the FSIS website.
Under a regulation effective in August 2008, FSIS will list on its website the
retail stores receiving meat and poultry products involved in Class I recalls.55 Some
of the retail stores subject to the regulation include supermarkets and grocery stores,

45 Id.
46 Id.
47 A list of all FSIS recalls since 1994, and related information, can be accessed at
[ h t t p : / / www.f s i s .us da .gov/ Fs i s _ Re c a l l s / ] .
48 FSIS Directive 8080.1, part IX.A.
49 To Review Recent Recalls in the Meat Industry: Hearing before the H. Comm. On
Agriculture, 110th Cong. 11 (2007) (statement of Richard Raymond, Under Secretary for
Food Safety, U.S. Department of Agriculture), [


50 FSIS Directive 8080.1, part IX.A.
51 Id.
52 Id.
53 Id.
54 FSIS Directive 8080.1, part IX.B.
55 9 C.F.R. § 390.10; 73 Fed. Reg. 40948. See also News Release, U.S. Dept. of Agriculture,
USDA Will List Retail Stores Receiving Recalled Meat and Poultry Products (July 11,


convenience stores, meat markets, wholesale clubs and supercenters.56 FSIS noted
that the listing is intended to better inform consumers about products that have the
greatest potential for serious health consequences.57
Monitoring and Termination of Recalls. FSIS monitors the recall process
through effectiveness checks. The effectiveness checks verify the diligence and
success of the recalling firm in notifying consignees (those entities or individuals to
whom the product has been delivered) of the recall and the response of the58
consignees. They are based on the risk involved, the recall classification, and the
number of consignees.59
FSIS personnel contact or visit consignees to determine the effectiveness of a60
recall. When the number of consignees that are found to have the product available
to the public exceeds the critical limit provided in FSIS sampling plans, the recall61
cannot be deemed effective. If the number is equal to or less than the critical limit,
the recall is deemed effective.62
If FSIS finds a lack of prompt action by a firm or a lack of response by
consignees to a firm’s request, the agency may exercise its authority to detain any
product found in commerce.63 When a firm does not or cannot implement a proper
recall strategy, FSIS may intervene under its detention authority or provide public
warnings in order to mitigate the risk posed by the product.64
FSIS issues a recall termination report after it completes effectiveness checks65
and determines that all reasonable efforts have been made to recall the product.
These reports may also be issued if the firm disposed of the product that was in66
commerce during the recall or if the product is held under FSIS control.
Termination reports indicate the amount of recovery and method of disposition.67

56 73 Fed. Reg. 40946.
57 73 Fed. Reg. 40940.
58 FSIS Directive 8080.1, part X.
59 Id.
60 FSIS Directive 8080.1, part X.E. For specific information on effectiveness checks
(including tables that provide the critical limits), see Attachment 3 of the Directive.
61 Id.
62 Id.
63 FSIS Directive 8080.1, part X.F.
64 FSIS Directive 8080.1, part X.G.
65 FSIS Directive 8080.1, part XI.
66 Id.
67 Id.

Selected Issues and Bills68
Proposals have been debated in past sessions of Congress to provide FSIS with
the authority to order companies to recall meat and poultry. However, none has been
enacted. A number of bills with recall-related provisions are pending again in the

110th Congress.69 Following is a brief discussion of selected issues and bills.

Is Mandatory Authority Needed? Consumer and food safety advocacy
groups have long argued that FSIS (as well as FDA) should be granted explicit
statutory authority to impose mandatory recalls of adulterated and misbranded
products. These advocates contend that FSIS (and FDA) needs such authority to
ensure products can be quickly removed from the market any time a company
declines to do so voluntarily, is reluctant to act swiftly, or fails to conduct a
comprehensive recall. Mandatory authority would expedite the current process, make
it clear that public health is the agencies’ top priority, reduce companies’ exposure
to lawsuits, and bolster consumer confidence in the food supply, they maintain. In
2004, GAO concluded that FSIS and FDA do not know how well companies carry
out recalls, and have not effectively tracked them. As a result, most recalled food
products are not recovered and thus may be consumed, GAO found.70
Others, including meat and poultry industry trade associations and some
Administration officials, have countered that current authorities are sufficient. Few
if any meat or poultry establishments have refused to comply with an FSIS
recommendation to recall a suspected contaminated product, they argue. (Critics
contend that this claim is based upon anecdotal reports rather than a factual
accounting.) Industry representatives assert that FSIS’s existing authority to suspend
or withdraw its inspection service, which effectively denies a plant the right to
market its products, is a strong incentive for establishments to ensure their products
are safe to consume. FSIS’ authority also enables it to detain meat and poultry
products of concern for up to 20 days, and the agency can, with a court’s permission,
seize, condemn and destroy unsafe food as well. These implicit threats, along with
the potential for adverse publicity and legal liability, make the current system
effective, its proponents maintain.

68 Among the sources for the pro-con arguments in this section is Roberts, Michael T.,
Mandatory Recall Authority: A Sensible and Minimalist Approach to Improving Food
Safety, bepress Legal Series, Working Paper 258 (April 27, 2004), available at
[ expresso/eps/258/].
69 Not discussed here are a number of other bills that also have been introduced with
mandatory recall language, but they appear to affect FDA exclusively. These include the
Food and Drug Import Safety Act of 2007 (H.R. 3610), the Consumer Food Safety Act of

2007 (H.R. 3624), and the Food Import Safety Act of 2007 (H.R. 3937).

70 Government Accountability Office, Food Safety: USDA and FDA Need to Better Ensure
Prompt and Complete Recalls of Potentially Unsafe Food (October 2004), [http://www.gao.
gov/new.items/d0551.pdf]. An earlier GAO (then called the General Accounting Office)
report critical of current recall policies was Food Safety: Actions Needed by USDA and FDA
to Ensure That Companies Promptly Carry Out Recalls, GAO/RCED-00-195, August 2000,
[ h t t p : / / a r c hi ve / 2000/ r c 00195.pdf ] .

It is also argued that voluntary procedures encourage cooperation between
industry and its regulators, whereas mandatory recall authority might discourage it.
Mandatory authority would foster a more adversarial system of mistrust and possible
litigation, making recalls less rather than more effective, they argue.
The House Agriculture Subcommittee on Livestock, Dairy, and Poultry held a
November 7, 2007 hearing to review recent FSIS recalls. Responding to questions
from several subcommittee members, USDA Under Secretary for Food Safety Dr.
Richard Raymond reiterated the Department’s view that it does not need additional
enforcement tools, including mandatory recall authority. A day earlier, the Bush
Administration had announced a new food safety strategy proposing such authority
for FDA, however.71
Several pending bills would provide mandatory recall authority for products
currently regulated by FSIS. Under the Safe and Fair Enforcement and Recall for
Meat, Poultry, and Food Act of 2007 (H.R. 3484), all appropriate persons first would
be given the opportunity to cease distribution of a potentially unsafe product, recall
it, and to notify all others in the marketing chain including consumers, and state and
local health officials. The bill would further direct FSIS to mandate such actions if
voluntary actions are not undertaken in a timely fashion. Comparable provisions in
the bill would cover poultry and poultry products.
Several other bills would authorize a new agency to mandate a recall, if
voluntary recall actions are not sufficient. These include the Safe Food Act of 2007
(H.R. 1148/S. 654), which is a much broader proposal to consolidate all federal food
safety responsibilities under a new Food Safety Administration (FSA), and the Food
and Product Responsibility Act of 2007 (S. 2081). This proposal also would require
anyone who distributes food products — including meat and poultry products — to
have certification that he/she is financially capable of paying for the entire cost of a
recall of that product if necessary, including any associated administrative costs.
Responsibility Questions. Among other components that might be
considered for a “sensible” mandatory food recall system, according to the Roberts
article,72 are: extension of due process protection to food companies (i.e., a hearing
before an administrative law judge); and possibly some limitation on the liability of
companies that comply with a government recall request, to protect them from civil
These particular aspects of the issue apparently have not been widely discussed
among stakeholders, at least not publicly. More specifically, if Congress empowered
FSIS with mandatory recall authority, would it also be shifting — whether implicitly
or explicitly — the burden of proof from the companies to the agency? Might FSIS’s
reasons for ordering a recall be subject to protracted challenge during the hearing
proceedings, potentially undermining the recall’s effectiveness? What if FSIS

71 U.S. Department of Health and Human Services, FDA, Food Protection Plan: an
integrated strategy for protecting the nation’s food supply, November 2007, at
[http://www.fda.go v/ oc /initiatives/advance/food/plan.html ].
72 See Roberts, supra note 65.

erroneously ordered a recall “out of an abundance of caution” that ultimately caused
a business to fail, on the one hand? If, on the other hand, FSIS waited until it had
additional evidence of problems, would it be jeopardizing consumer safety?
Notification Requirements. FSIS does not have explicit statutory authority
to require a company to notify it when the company has distributed an unsafe product73
or knows that such a product is in commerce. Many, including Roberts, believe that
such a mandate for prompt notification is a prerequisite for an effective recall policy.
In the enacted 2008 farm bill, Section 11017 (“Food Safety Improvement”)
amends both the FMIA and PPIA to require any establishment subject to inspection
to “promptly notify” USDA if it believes, or has reason to believe, that an adulterated74
or misbranded meat or poultry product has entered commerce. Section 11017 also
requires meat and poultry establishments to prepare and maintain recall plans and any
reassessments of their process control plans and to have them available for USDA
inspectors to review and copy.
Other pending bills also include mandatory notification language. For example,
H.R. 1148/S. 654 would require any person with reason to believe that a food
entering commerce is in violation of the law to immediately notify the newly
established FSA. H.R. 3484 and S. 2081 also would require persons (other than
household consumers) to notify the Department as soon as practicable if they had
reason to believe that a carcass, carcass part, meat, or meat food product they are
handling is adulterated or misbranded. Another somewhat different measure, the
Ending Agricultural Threats: Safeguarding America’s Food for Everyone (EAT
SAFE) Act of 2007 (S. 2418), would provide for mandatory public notification of
food products that have been fraudulently brought into the United States.
In response to the Westland/Hallmark recall of beef products that were
distributed to school lunch and federal nutrition programs, H.R. 5762 would require
anyone who voluntarily recalls meat, poultry, or egg products to submit to the
Secretary a list of retail stores or public school districts known to have purchased
products subject to the recall within five days after the recall began. That person
would also be required to notify the Secretary of any store or district that was not
included on the original list within five days of learning of the omission. The
Secretary must make this information publicly available within five days of receiving
it. The bill would also amend the definition of adulterated meat to include that
derived from nonambulatory cattle.
Traceability. Effective recalls require that industry and government officials
have the means to easily trace the movement of products. Some argue that improved

73 Id.
74 This notification requirement is in lieu of a somewhat more prescriptive provision in the
Senate-passed version that would have created “reportable” meat and poultry registries. The
registries would have been similar in concept to the registry in the Food and Drug
Administration Amendments Act of 2007 (P.L. 110-85), which now requires the Secretary
of HHS to create a registry for reporting FDA-regulated foods with safety problems.

traceability capabilities would facilitate determining a product’s source and
whereabouts, and better prevent or contain foodborne illness outbreaks.75
Several pending bills would require FSIS to establish programs to achieve these
goals. The Tracing and Recalling Agricultural Contamination Everywhere (TRACE)
Act of 2007 (H.R. 3485) would require FSIS to establish a system enabling it to
retrieve the history, use and location of a meat or poultry food, from the animal of
origin and its locations prior to slaughter, through processing and distribution to the
ultimate consumer. The system would include recordkeeping and auditing elements.
The Meat and Poultry Products Traceability and Safety Act of 2007 (S. 1292) also
would require FSIS to establish a meat and poultry traceability system covering all
stages of production, processing, and marketing, from live animals before slaughter
to distribution of finished products to the ultimate consumer. S. 1292 would require
persons and companies to maintain records and allow access to them when needed
to trace products. H.R. 1148/S. 654 also contains traceability requirements.
Recovery Rates and Recall Effectiveness. Recalls rarely recover all
products.76 Since 1994, the quantity of products actually found have constituted
anywhere from 17% to 28% annually of the total pounds recalled. (Recoveries did
reach 64% in 2004, 40% in 1997 and 58% in 1996.) Among the reasons that many
products are not recovered is that they likely have been consumed or destroyed by
purchasers, according to FSIS. One issue is whether recoveries offer evidence that
recalls are effective. FSIS officials have asserted on several occasions that “pounds
recovered” is not a reliable measure of recall effectiveness, preferring to evaluate its
success on such factors as whether the number of illnesses associated with an
outbreak has been halted since a recall was announced and “whether or not the77
product has stopped flowing through the distribution chain.” Notwithstanding these
assertions, the 2004 GAO report claims that both FSIS and FDA “told us recovery78
was an important indicator of a successful recall.”
FSIS testified that it has improved the effectiveness of the recall process since
the release of the critical OIG report. In 2004, FSIS included revisions in Directive

8080.1 designed to enhance recall verification instructions to agency officials. The

75 Traceability has also been debated in connection with protecting against agroterrorism,
and for verifying the U.S. origin of live animals and their products for marketing, trade
and/or animal health purposes. See also CRS Report RS22653, Animal Identification:
Overview and Issues, by Geoffrey S. Becker.
76 According to one analysis of FSIS recall data, the average recovery rate per recall is 44%
over the past two years and “for five recalls that followed reports of consumer illness,
recovery rates per recall averaged just 20%.” Julie Schmit and Barbara Hansen, “Most
Recalled Meat Isn’t Recovered,” USA Today, December 3, 2007, at 1B.
77 See for example “Recalls v. Recoveries,” USDA responses to questions by Representative
Kaptur, Agriculture, Rural Development, Food and Drug Administration, and Related
Agencies Appropriations for 2007, Hearings before a House Appropriations Subcommittee
(Part 1), pp. 292-293, 2006.
78 Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of
Potentially Unsafe Food, p. 15.

agency also stated that it has increased the number of effectiveness checks and
shortened their completion times. Such checks rely on
... a risk-based statistical sampling plan to determine the number of consignees
that FSIS program personnel will contact during the effectiveness checks. For
a recall to be deemed effective or successful, the number of consignees found to
have a product in commerce must be equal to or less than a critical number79
established in the FSIS risk-based recall effectiveness checks sampling plan.
FSIS also published a final rule on July 17, 2008, providing for the agency to
post on its website a list of all retail outlets to which a recalled product has been
distributed. In response to comments received, FSIS limited the application of the
rule to Class I recalls only. The agency believes that this would enable consumers
to identify, and return or destroy, more products than currently are found.80
Significance of Recall Data. Another issue is the usefulness of recall data
generally. Does a high number of recalls indicate that current food safety measures
are ineffective in keeping unsafe products off the market? Or, rather, does it signify
that industry and the federal government have heightened testing, improved their
ability to find the sources of more foodborne illness outbreaks, and have otherwise
become more vigilant in their oversight, even after the products leave the plants?
USDA Under Secretary Raymond was asked at a House Appropriations
subcommittee hearing about the significance of recall numbers. He responded that
the number had declined in recent years, and that “... it tells me that our food safety81
system has improved dramatically.”
In arguing that their own inspection programs provide at least as much safety
at the federal program, states have long made the claim that they experience far fewer
recalls of their inspected products than does FSIS. However, might it be argued that
states conduct fewer recalls because they maintain a different level of vigilance than
FSIS? One consumer advocate told CRS that most recalls of federally inspected
products are announced after routine FSIS or plant testing finds instances of bacterial
contamination or potential contamination — not necessarily in response to a
foodborne illness outbreak. By contrast, she asserted, neither states nor state-

79 USDA responses to questions by Chairman DeLauro, Agriculture, Rural Development,
Food and Drug Administration, and Related Agencies Appropriations for 2008, Hearings
before a House Appropriations Subcommittee (Part 4), pp. 3358-359, 2007. These pages
contain additional details on how FSIS checks effectiveness, but does not appear to shed
light on how the agency arrives at its “critical number” benchmarks.
80 73 Fed. Reg. 40939 - 40948.
81 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations for 2008, Hearings before a House Appropriations Subcommittee (Part 4),
p. 289, 2006. Others have pointed out that even the record 60.9 million pounds recalled in
2002 represented only 0.06% of the 92.3 billion pounds of meat and poultry inspected at
slaughter that year.

inspected plants have done as much testing.82 A representative of the state agencies,
on the other hand, speculated that states tend to hold products until testing is
completed and verified, so that contamination may more likely be discovered before
a product enters commerce.83,84

82 Carol Tucker Foreman, Consumer Federation of America, personal communication,
October 15, 2007.
83 National Association of State Departments of Agriculture, personal communication,
October 15, 2007.
84 States also are responsible for inspecting significantly fewer pounds of meat and poultry.
For example, FSIS inspected a total of 96.4 billion pounds of meat and poultry in FY2004.
Another 4.2 billion pounds were imported meat and poultry that were subject to border
re-inspection by FSIS. By contrast, states inspected approximately 500 million pounds of
meat and poultry in FY2004, or 5% of the volume of FSIS-regulated products. See also
CRS Report RL34202, State-Inspected Meat and Poultry: Issues for Congress, by Geoffrey
S. Becker.

Appendix. Information Regarding Meat and
Poultry Product Recalls
Recent Recalls
FSIS reported 773 meat and poultry recalls, representing nearly 300 million
pounds of products, from January 1, 1994 through November 30, 2007, the period
of time examined by CRS because the data were readily available. Of the total, 73%
were Class I recalls, 19% Class II recalls and 8% Class III recalls (CRS calculation
based on FSIS recall data).
Listeria monocytogenes, usually on ready-to-eat products, and E. coli O157:H7,
almost always involving ground beef, hamburger patties, and other raw cuts of beef,
together constitute the majority of reasons for recalls. Measured by volume of
products, these two pathogens alone accounted for more than 80% of the total pounds
recalled during the period. More specifically, Listeria concerns were associated with

243 or 31.4% of all recalls (and a total of more than 146 million pounds or 48.9%)

from 1994 through November 2007. E. coli O157:H7 concerns were associated with

150 or 19.4% of all recalls (and a total of more than 97 million pounds or 32.4%).

Of the total number of recalls, 164 or 21.2% were a variety of products found
to be misbranded, often because they contained an undeclared substance or
ingredient. These substances were frequently allergens such as undeclared nuts in
a processed product. Another 67 or 8.7% of all recalls during the period, again of a
variety of products, were due to reports of foreign materials — from sharp objects
such as glass or metal to potentially less hazardous matter such as pieces of plastic
wrap. Another 149 recalls or 19.3% were from a number of different causes, ranging
from processing defects like undercooking to ineligible imports (i.e., from countries
or foreign plants not determined to have equivalent safety systems).

Figure 1. FSIS Meat and Poultry Recalls,
January 1994-November 2007
12 0
10 0
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
E. coliListeriaTotal
Source: Prepared by CRS based on FSIS data.
Figure 2. FSIS Meat and Poultry Recalls,
January 1994-November 2007

70 ,0 00
60 ,0 00s
50 ,0 00s a nd
40 ,0 00ou
30 ,0 00n
20,000unds i
10 ,0 00P
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
E. coliListeriaTotal
Source: Prepared by CRS based on FSIS data.

Figure 3. Recalls by Reason,
January 1994-November 2007
Misbranded/Undeclared Number
Po un ds
48.9% sub s.
Lis t er ia31. 4% Othe r
5.8 %
Other19.3%Foreign Material
E. coliForeign MaterialE. coli
19.4% 8.7% 32 .4%
Source: Prepared by CRS based on FSIS data.
Figure 4. Recalls by Product Type,
January 1994-November 2007

Mixed, other or NumberMixed, other Pounds
Beef & processed unspecifiedBeef & or
products14.9%processed productsunspecified23%
31 .2% 35 .9 %
Sausage (any species)Sausage
11.4%(any species)1.5%
Franks (any species)Franks (any species)
8.7%Poultry & 14.3%
Pork, ham & processed Pork, ham & processed Poultry &
processed productsproducts21.2%productsprocessed products
12 .6% 0.9 % 25.0%
Source: Prepared by CRS based on FSIS data.
As Figure 1 shows, recall volumes have varied significantly from year to year.
Years with large overall volumes typically were because just one or two of the total
recalls for that year involved a large quantity of products produced by a single
company. For example, 25 million pounds, of the total of 28.3 million pounds of
recalled products in 1997, can be attributed to a Hudson Foods recall of ground beef
products on August 12 of that year due to E. coli O157:H7 contamination. This was
one of the eight largest recalls during the period examined (see Table 1). Four of
these recalls are discussed following the table.

Table 1. Largest Recalls Since 1994
Dat e Com pany P roduct Reason P ounds
AugustHudsonground beef E. coli O157:H725
DecemberBil Marfranks; packagedListeria35
JanuaryThorn Applepackaged meatsListeria35
DecemberCargillready-to-eat poultryListeria17
April 2001Bar-S Foodsmeat & poultryListeria14
June 2002ConAgraground beef E. coli O157:H718
OctoberPilgrim’spoultry productsListeria27
SeptemberToppsground beef E. coli O157:H722
FebruaryWestland/raw & frozen beefdowner cattle not143
2008Hallmarkproductscleared for
Source: USDA, FSIS, Recall Archives.

Note: Pounds rounded to nearest million.
Recall 005-2008, Beef Products. On February 17, 2008, USDA announced
that Westland/Hallmark Meat Co. of Chino, California, was recalling 143.4 million
pounds of fresh and frozen beef products dating to February 1, 2006. Approximately
50 million pounds were distributed to the school lunch and several other federal
nutrition programs in 45 states.
This was the largest U.S. meat or poultry recall ever. It came after FSIS found
evidence that the establishment had a practice of occasionally allowing the slaughter
of cattle that had become nonambulatory after they had been inspected, but before
they were slaughtered for human food. FSIS regulations explicitly prohibit
nonambulatory (“downer”) cattle in human food because they are more likely to have
bovine spongiform encephalopathy (BSE, or “mad cow disease”).
The recall was so-called Class II, indicating a remote possibility that
consumption of the products could cause adverse health effects. (Most large recalls
are Class I, with a reasonable probability that the product could cause serious health
consequences or death.) USDA stated that most of the recalled beef likely had been

consumed, and that schools and other nutrition outlets had been instructed to hold
and eventually destroy all remaining products.
FSIS had suspended inspection at the plant on February 4, 2008, three days after
the plant voluntarily ceased operations pending an investigation of inhumane
practices there. These came to light after animal welfare advocates secretly
videotaped what they described as employees inhumanely handling downer cattle
before slaughter. USDA inspectors reportedly had failed to detect that these animals
became nonambulatory after they had received antemortem inspection — causing
some to question the effectiveness of recent increased appropriations from Congress
for more aggressive enforcement of the federal Humane Methods of Slaughter Act
(7 U.S.C.1901 et seq.). The act requires meat establishments to handle and kill
livestock using prescribed humane practices.85
Recall 040-2007, Ground Beef Products. On September 25, 2007, FSIS
announced that Topps Meat Company, LLC, an Elizabeth, NJ, establishment, was
voluntarily recalling approximately 331,582 pounds of frozen ground beef products
because they might be contaminated with E. coli O157:H7. On September 29, the
recall was expanded to 21.7 million pounds; on October 6, FSIS notified the public
that several more product labels (but no additional pounds of products) were being
added to the recall. FSIS officials said that this recall case was unusual in that it
arose from a patient-reported illness (forwarded on August 31, 2007) thought to be
caused by E. coli. The same day, according to FSIS, a field investigator collected a
sample of leftover product from the patient’s freezer for testing, and the laboratory
returned a positive finding of E. coli O157:H7 from that sample on September 7.
It took a series of follow-up tests and meetings before FSIS was ready to tie the
illness — and other similar illnesses — to the Topps plant, with the recall announced
on September 25. By October 6, the Centers for Disease Control (CDC) had cited

32 illnesses that appeared to be related to the recall.

According to trade press reports, the initial (September 25) recall covered three
days of ground beef production (June 22, July 12, and July 23, 2007). The expansion
to 21.7 million pounds covered one year of production (back to September 25, 2006),
because the plant was carrying over (reworking) each day’s production to the next,
rather than processing the ground meat in separate batches, which would create a
clean break in production, a critical control stressed by industry experts and FSIS
officials. In addition, the plant had not followed its own HACCP plan, according to
the reports.86 More specifically, for example, reports indicated that the plant
appeared to be grinding meat that did not carry the necessary documentation showing
that it had been tested by the supplier for contamination. At the same time, the FSIS
inspector who visited the plant daily (but was not there continuously), did not

85 For additional background see CRS Report RS22819, Nonambulatory Livestock and the
Humane Methods of Slaughter Act, by Geoffrey S. Becker.
86 See for example, Cattle Buyers Weekly, October 8, 2007; Feedstuffs, October 8, 2007.

uncover the problem, either. As of this writing, it is not clear whether the company,
which has since ceased operations, had a recall plan in the plant’s HACCP plan.87
Recall 055-2002, Beef Trim and Fresh and Frozen Ground Beef
Products. On June 30, 2002, FSIS announced that ConAgra Beef Company of
Greeley, CO, was voluntarily recalling approximately 354,200 pounds of fresh and
frozen ground beef products that may have been contaminated with E. coli O157:H7.
On July 19, 2002, FSIS announced that the recall had been expanded to
approximately 19 million pounds (later re-estimated to be 18 million pounds) of fresh
and frozen ground beef products, along with beef trim. The recall was initiated after
at least 46 people in 16 states became ill from contaminated meat, beginning in mid-
June 2002. Testing confirmed that many of the illnesses were from the same strain
of E. coli that had been found in beef tested at the Greeley plant as early as April 12,

2002 and as late as July 12, 2002.88

The USDA Office of Inspector General (OIG) report critiqued FSIS’s oversight
of the recall, characterizing it as “ineffective and inefficient because adequate
controls and processes were not in place to timely identify the source (establishment)
of the contaminated product or provide reasonable assurance that recovery of the
recalled product was maximized or enforcement actions taken, as necessary.” OIG
noted that only about 3 million pounds of 18 million pounds were recovered. Among
problems observed by OIG: “Neither FSIS nor the processing plants involved ... were
prepared for the possibility of a recall. Although FSIS encourages all establishments
to prepare recall plans, HACCP plans for two of the grinders using ConAgra beef did
not address recall procedures. One of these grinders was unable to readily determine
from its records which of its customers received the recalled product.”89
Recall 090-2002, Turkey and Chicken Products. On October 9, 2002,
FSIS announced that Pilgrim’s Pride Corporation (Wampler Foods) of Franconia,
PA, was recalling 295,000 pounds of fresh and frozen ready-to-eat poultry products
due to possible contamination with Listeria monocytogenes. The announcement
came after FSIS found that a sample taken from the plant on October 2 had tested
positive for Listeria. On October 12, the recall was expanded to approximately 27.4
million pounds of the products, produced between May 1 and October 2, 2002, which
Pilgrim’s Pride had distributed throughout the country and overseas. Some went to
school feeding agencies. Although product samples from various days of production
were all negative for the bacteria, environmental sampling in the plant itself matched
the strain of Listeria found in the October 9 recalled product, according to FSIS.
Operations had been suspended at the plant but resumed on November 14, 2002.

87 See the recall announcements at [
88 USDA, Office of Inspector General (OIG) Audit Report, Food Safety and Inspection
Service Oversight of Production Process and Recall at Conagra Plant (Establishment 969)
(Report. No. 24601-2-KC) at ii, September 2003, available at [
/webdocs/24601-2-K C%20conagr a%20091603.pdf].
89 Id. at iv.

This recall was terminated on July 11, 2003, after the reported recovery of more
than 5.5 million pounds (much of the rest was likely consumed or discarded by
consumers), and FSIS declared it effective. However, OIG found that FSIS’s
oversight was ineffective, finding “an overwhelming number of significant
discrepancies on the agency’s effectiveness check forms that call [FSIS’s] conclusion
into question.”90
Recall 015-1997, Frozen Ground Beef Patties. On August 12, 1997,
FSIS announced that Hudson Foods of Rogers, AR, was recalling approximately
20,000 pounds of frozen ground beef patties distributed nationwide because the
product might be contaminated with E. coli O157:H7. This occurred after several
Colorado consumers were reported to have become ill from the bacterium after
consuming the Hudson product, and subsequent testing found the same strain in a
Hudson patty. The recall was expanded to over 1.2 million pounds on August 15 and
reached 25 million pounds by the time it was officially ended on February 9, 1999.
The plant that produced the patties in Columbus, NE, was closed. Approximately

10.1 million pounds of beef were eventually recovered.

The initial recall was limited to 20,000 pounds even though the plant produced
400,000 pounds per shift — and though meat from one day was being reworked into
hamburger being produced on subsequent days, which led to the greatly expanded
recall. (This was the same problem that re-emerged 10 years later in the Topps
recall.) “The Hudson recall was viewed as an example of the breakdown of the
voluntary food recall system. Critics noted that FSIS’s lack of recall authority results
in dangerous delays when companies such as Hudson question the extent or basis for
a recall and wait before acting,” Roberts wrote, suggesting it was an argument for91
mandatory recall authority.

90 USDA, Office of Inspector General (OIG) Audit Report, Food Safety and Inspection
Service Effectiveness Checks for the 2002 Pilgrim’s Pride Recall (Report. No. 24601-02-
Hy) at i, June 2004, available at [].
91 Mandatory Recall Authority: A Sensible and Minimalist Approach to Improving Food