[Federal Register Volume 73, Number 138 (Thursday, July 17, 2008)]
[Rules and Regulations]
[Pages 40939-40948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16221]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 73, No. 138 / Thursday, July 17, 2008 / Rules
and Regulations
[[Page 40939]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 390
[FDMS Docket Number FSIS-2005-0028]
RIN 0583-AD10
Availability of Lists of Retail Consignees During Meat or Poultry
Product Recalls
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations to provide
that the Agency will make available to the public the names and
locations of the retail consignees of meat and poultry products that
have been recalled by a federally-inspected meat or poultry
establishment if the recalled product has been distributed to the
retail level. This rule will apply only where there is a reasonable
probability that the use of the recalled product will cause serious
adverse health consequences or death (Class I recalls).
FSIS will routinely post this information on its Web site as it
compiles the information during its recall verification activities.
FSIS is taking this action to provide an additional mechanism for
prompting consumers to examine products stored in their refrigerator,
freezer, or cupboard when there is a reasonable probability that the
product will cause adverse health consequences. The retail consignee
information will complement the product identification information that
FSIS already makes available and will provide additional opportunities
for local media outlets and State and local health officials to
transmit more targeted information about the recall to consumers.
EFFECTIVE DATE: August 18, 2008.
FOR FURTHER INFORMATION CONTACT: Philip Derfler, Assistant
Administrator, Office of Policy and Program Development, Room 350-E,
Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington,
DC 20250; Telephone (202) 720-2709, Fax (202) 720-2025.
SUPPLEMENTARY INFORMATION:
I. Background
FSIS is responsible for ensuring that meat and poultry products are
safe, wholesome, and accurately labeled. FSIS enforces the Federal Meat
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).
These two statutes require Federal inspection and provide for Federal
regulation of meat and poultry products prepared for distribution in
commerce for use as human food. When there is reason to believe that
meat or poultry products in commerce are adulterated or misbranded,
FSIS requests that the establishment that introduced the products into
commerce recall them. If the establishment does not agree to recall the
products, FSIS has the authority to detain and seize the products.
When an establishment recalls products, it is responsible for
promptly notifying each of its affected consignees about the recall. In
general, the recalling establishment conveys the following information
to its affected consignees:
That the product in question is subject to a recall;
That further distribution or use of any remaining product
should cease immediately;
Where applicable and required as part of the recall
strategy, that the direct consignee should in turn notify its
consignees that received the product about the recall;
Instructions regarding what to do with the product; and
Contact information for questions (e.g., a name and toll-
free number).
Affected consignees carry out instructions provided to them by the
recalling establishment and, when necessary, extend the recall to their
consignees.
FSIS also widely disseminates recall information. For Class I or II
recalls, defined in FSIS Directive 8080.1, Revision 4, Recall of Meat
and Poultry Products, dated 5/24/04\1\, as those situations where there
is a reasonable (Class I) or remote (Class II) probability that the use
of the product will cause serious adverse health consequences, FSIS
typically issues a press release and distributes recall information to
wire services and media outlets in the areas where the product was
distributed. FSIS also alerts Congressional delegations and public
health partners, such as the Association of Food and Drug Officials,
and State departments of health and agriculture, concerning these
recalls and posts the recall information on the FSIS Web site. For
Class III recalls, defined as those situations where the use of the
product will not cause adverse health consequences, FSIS usually does
not issue a press release (except in cases of egregious economic
adulteration). It distributes a Recall Notification Report (RNR) to the
appropriate Federal, State, and local public health and food inspection
agencies and posts it on FSIS' Web site.
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\1\ http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/8080.1Rev4.pdf
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Through press releases and RNRs, FSIS provides the public with
pertinent information about the recalled products. To help consumers
identify the product, FSIS provides a description of the food being
recalled; any identifying codes, including lot numbers, when available;
the reason for the recall; the name and official number of the
producing establishment; the types of establishments and facilities to
which the recall extends; the availability of product at the retail
level; FSIS' classification of the recall; pictures of the product or
label, when available; and the appropriate contact persons for FSIS and
the recalling company. FSIS lists those States to which recalled
product was shipped if fewer than 13 States were involved in the
recall. If the recall extends to 13 or more States, it is considered a
nationwide recall. To date, FSIS has not publicized the names or
locations of the retail consignees that received recalled meat or
poultry products, although FSIS has on occasion, identified a store or
chain if it was the sole retail outlet for the recalled product.
During the recall process, FSIS obtains from the recalling
establishment the names of the known consignees of the recalled product
(based on its
[[Page 40940]]
records). These consignees may include distributors, warehouses, and
retailers.\2\ FSIS uses this information to contact all of recalling
establishment's affected consignees in order to verify that the
establishment has notified all of them of the recall, and that the
consignees have removed the recalled products from the market and
disposed of them as directed by the recalling establishment.
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\2\ This final rule applies to FSIS-regulated meat and poultry
products only.
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FSIS also compiles lists of all subsequent consignees to which the
recalling establishment's direct consignees distributed the recalled
product by contacting those consignees to ensure that they were also
notified of the recall. The Agency traces the recalled product forward
to the retail level. When there is concern that the original
distribution information is not accurate or complete, e.g., a generic
list of chain stores is missing a few known stores, FSIS will prepare a
list identifying the consignees or distributors that may have received
the recalled product but were not included in the distribution
information provided by the firm.
Through this process, as well as that of verifying the
effectiveness of the recalling establishment in conducting the recall,
FSIS develops a list of consignees, down to and including the retail
level, that have, or have had, the recalled products in their
possession. FSIS begins its process of verifying the effectiveness of
the recalling establishment in conducting the recall, which is
described in FSIS Directive 8080.1, as soon as possible within three
working days of the initiation of a Class I recall and substantially
completes it within 10 working days of the initiation of the recall.
On March 7, 2006, FSIS published a proposed rule in the Federal
Register (71 FR 11326) in which the Agency proposed to post on its Web
site the names and locations of the retail consignees of recalled meat
and poultry products. FSIS proposed to post this information as the
Agency obtained it during its recall verification activities described
above. The proposal was developed by FSIS after its evaluation of
requests from consumer groups and some State officials, who advocated
the public release of information on where recalled meat and poultry
products have been shipped or distributed. The State officials
requested that this information be provided to them without the
limitations imposed by FSIS' regulations,\3\ believing that they would
be better able to protect the public health with this information.
Similarly, some consumer groups asserted that the public could use this
information to identify more easily and effectively the product being
recalled. These State officials and consumer groups believe that making
the retail distribution information available will materially improve
the effectiveness of recalls.
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\3\ 9 CFR 390.9(a)(1) requires a written statement establishing
the State's authority to protect confidential distribution lists
from public disclosure and a written commitment not to disclose any
information provided by FSIS without the written permission of the
submitter of the information or the written confirmation by FSIS
that the information no longer has confidential status.
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FSIS solicited comments on the proposal for thirty days. In
addition, on April 24, 2006, FSIS held a public meeting to solicit
comments on the proposal. A transcript of that meeting can be found at
http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0009_Transcript.pdf.
Following requests made during the public meeting and written requests
submitted during the comment period, FSIS reopened the comment period
on May 10, 2007, and solicited comments for an additional 30 days. (71
FR 27211).
In response to the proposed rule and public meeting, FSIS received
almost 6,000 comments from consumers, consumer advocacy organizations,
industry representatives, Federal and State agencies, and professional
organizations. This number includes several comments made by
individuals at the public meeting and taken from the transcript of that
event. There was strong support for the rule from consumers, consumer
advocacy organizations, Federal and State agencies, and professional
organizations. Collectively, these individuals and groups filed 26
comments supporting the rule. The remainder of the comments supporting
the rule were form letters. FSIS received nine comments from industry
representatives opposed to the proposed rule. These comments expressed
generally similar objections to the rule.
After carefully evaluating the comments, FSIS has decided to adopt
the proposed rule with modifications. Specifically, the Agency has
decided to limit the application of this final rule to Class I recalls,
that is, recalls where the Agency has determined that there is a
reasonable probability that the use of the product will cause serious
adverse health consequences or death. FSIS proposed applying the rule
to all classes of recalls. However, after evaluating the comments,
including those that suggested that it is not necessary to make
publicly available retail consignee lists in situations where food
safety concerns are minimal, FSIS has concluded that it is prudent to
modify the rule to apply only to those recalls involving products where
there is a reasonable probability that the use of the recalled product
will cause serious adverse health consequences or death.
In addition, this final rule makes clear that FSIS will make
available the names and locations of all retail consignees of recalled
meat or poultry products that the Agency compiles in connection with a
Class I recall. The list will not be limited to those consignees that
are actually the subject of FSIS recall effectiveness checks, which was
how some commenters interpreted the proposed rule. Finally, FSIS
simplified and removed unnecessary text from the codified language.
II. Response to Comments
Some commenters asserted that knowing the names of retail
consignees would help members of the public make better informed
decisions in responding to recalls. Other commenters stated that
providing retailer names and locations would enhance the usefulness to
consumers of the information that FSIS already provides, such as the
States in which product was distributed, because consumers would be
more likely to check the meat and poultry products in their possession
if they regularly shop at a store that sold the product involved in a
recall. Therefore, these commenters believed that the overall
effectiveness of recalls would be increased. Some commenters stated
that the information currently provided by FSIS may not be sufficient
because consumers may not know where to look for product codes or
establishment numbers; others stated that this rule change is a common
sense solution that will help consumers to identify recalled products
if they have them in their possession and thus better protect
themselves from adulterated or misbranded products.
The Agency believes that its current recall system has been
effective, but when there is a reasonable probability that the product
will cause adverse consequences, it would be useful to provide an
additional mechanism for prompting consumers to examine products stored
in their refrigerator, freezer, or cupboard. The retail consignee
information will complement the product identification information that
FSIS already makes available and will provide additional opportunities
for local media outlets and State and local health officials to
transmit more targeted information about the recall to consumers.
[[Page 40941]]
If the name of a store where a consumer shops appears on the posted
list of consignees, it will very likely prompt the consumer to use
product-specific information to determine whether recalled product is
one he or she may have purchased and stored. If the consumer in fact
has the recalled product, he or she can take appropriate action to
either dispose of the product or return it to the retailer and not
consume it.
As noted by the commenters who supported this rule change, the
retail consignee information should be particularly helpful in recalls
involving products where the product identification information is
limited, such as non-branded product and meat and poultry products that
are packaged at the retail level. Products packaged at the retail store
usually do not bear the establishment number of the official
establishment that is recalling the product.
Some commenters favoring the rule suggested that FSIS list the
retail consignees in the press release because some people may not own
a computer or know how to find the information on the FSIS Web site.
In most cases, FSIS will not have information on retail consignees
available at the time the press release is issued, which generally
occurs before the recall verification activities begin. Of course, FSIS
will continue to provide in its press release the same important
information about the recalled products currently made available,
including a description of the food being recalled; any identifying
codes, including lot numbers, when available; the name and official
number of the producing establishment; the types of establishments and
facilities to which the recall extends; the availability of product at
the retail level; FSIS' classification of the recall; pictures of the
product or label, when available; and the appropriate contact persons
for FSIS and the recalling company in the press release.
FSIS intends to release the information regarding retail consignees
of products subject to a Class I recall as soon as possible during the
course of the recall. Generally, for Class I recalls, this information
should be available within three to 10 working days.
One commenter generally concurred with the proposal but suggested
that FSIS clarify the rule to explain that the posted information is
incomplete because only those retail locations selected by the Agency
in conducting recall effectiveness checks would be identified.
The commenter misunderstood the Agency's proposal. FSIS intends to
post the names and locations of all known retail consignees identified
as having received meat or poultry products subject to a Class I
recall, irrespective of whether the Agency conducted a recall
effectiveness check at that location. FSIS has modified 9 CFR 390.10 to
make this clear.
Several commenters supported the proposed rule but stated that it
did not go far enough. In addition to identifying the retail
consignees, they believe that FSIS should also make available the names
of intermediate consignees, including hotels, restaurants, food service
institutions, and intermediate distributors. Intermediate consignees
may receive product directly from the manufacturer or from a
distributor at the wholesale level. Intermediate consignees prepare
their products for immediate, on-site consumption, not for delayed
consumer preparation at home.
Several commenters supporting the rule believe that limiting
distribution information to retail consignees will create an
unnecessary hurdle for State or local public health agencies to
overcome to obtain timely distribution information. One commenter
stated that providing this information for food service establishments
would ``provide consumers greater protection from the risks associated
with tainted meat or poultry,'' while another suggested that
restaurants be included so that individuals are fully aware of the
scope of recalls.
FSIS is making no changes based on these comments, which are
outside the scope of this rulemaking. The Agency is taking this action
to provide an additional mechanism for prompting consumers to examine
products stored in their refrigerators, freezers, or cupboards when
there is a reasonable probability that the product will cause adverse
health consequences so that they can take appropriate action to either
dispose of the product or return it to the retail store at which it was
purchased. Making available the names of intermediate consignees will
not advance the purposes of this rulemaking because there is no reason
to believe that this information will help consumers to determine that
they have the recalled products in their possession.
Further, FSIS does not agree that publicly identifying food service
establishments would provide consumers greater protection from the
risks associated with tainted meat or poultry. To ensure that Class I
recalled products held by intermediate consignees do not reach
consumers, intermediate consignees that have recalled products in their
possession are obligated to segregate them from all other non-recalled
products and dispose of them as directed by the recalling
establishment. This is also true of recalled products held by retail
consignees. In addition, FSIS already has in place a process to share
distribution information, including the names and addresses of
intermediate consignees, with State and local public health agencies to
ensure that intermediate consignees have disposed of the recalled
product.\4\
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\4\ See 9 CFR 390.9.
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Several commenters opposed to the rule stated that adoption of the
proposal would hamper the currently effective recall procedures and
adversely affect public health. These commenters stated that providing
consumers with the names of retail consignees will hamper recall
efficiency because this information may be inaccurate, leading to
increased returns of product that has not been recalled. One commenter
stated that the lists of retail consignees will be untimely and may
lead to consumer apathy and failure to heed recall notices. A few
commenters stated that consumers have all the information they need to
identify recalled product, and that they do not require retail store
information to identify implicated product.
FSIS disagrees that publishing the names of retail consignees will
diminish the effectiveness of the Agency's recall procedures, hamper
identification of recalled product, or result in the release of
untimely or inaccurate information. As they currently do, the FSIS
verification procedures will ensure that any inaccuracies in the retail
consignee list are identified and corrected quickly. FSIS has
determined that starting to post the names and locations of retail
consignees within three working days of the initiation of a Class I
recall will make its lists timely. FSIS does not believe consumers will
ignore the product specific information that the Agency currently
provides to assist them in accurately identifying the recalled product.
Rather, retail consignee information will complement the product
identification information that FSIS already makes available and will
provide additional opportunities for local media outlets and State and
local health officials to transmit more targeted information about the
recall to consumers.
Further, FSIS notes that in some recalls, product specific
information is limited. Some products do not bear product codes or
establishment
[[Page 40942]]
numbers. They are packaged at the retail level and thus have limited
identification. In 2007, almost 9 percent of the recalled meat and
poultry products sold at retail stores were non-branded. Providing the
names and locations of retail consignees, in conjunction with the other
information provided, in these cases, will be particularly important
for prompt identification.
In addition, for a variety of reasons, consumers may remove product
from the original packaging and store it in containers that lack the
identification information. In these situations, publishing only the
establishment number, product codes, and States where the product was
distributed is of little use to the consumer. However, identifying the
retail store at which the product was available for sale by name and
location provides consumers with additional information that will
trigger efforts on their part to determine whether they purchased the
recalled product.
FSIS is providing this information on the retail consignees of a
Class I recalled product so that consumers can use it in conjunction
with the information the Agency already provides to identify the
recalled products and to act appropriately with respect to those that
have actually been recalled. Returning recalled products to the store
at which they were purchased is just one option consumers have.
Consumers may also dispose of such products at home. The objective of
the rule is to provide an additional mechanism for prompting consumers
to examine products stored in their refrigerator, freezer, or cupboard
when there is a reasonable probability that the product will cause
adverse health consequences. The retail consignee information will
complement the product identification information that FSIS already
makes available and will provide additional opportunities for local
media outlets and State and local health officials to transmit more
targeted information about the recall to consumers.
In response to commenters and to ensure that consumers do not
misunderstand the retail consignee list, FSIS will provide the
following explanatory statement that will accompany the list that will
make it clear that the list is still under development:
FSIS has reason to believe that the following retail locations
received [describe meat or poultry products that are subject of
recall] that has been recalled by [name of company]. This list may
be incomplete. Please use the product-specific identification
information, which is available at [insert link to specific recall]
to check meat or poultry products in your possession to see if they
have been recalled.
FSIS continues its investigation in conjunction with this recall
and will update this list, as appropriate.
Significantly, the statement gives the Agency an opportunity to
urge people to consult the identifying information about the product.
Some of the commenters opposed the rule because they believed that
the provision of incomplete lists of retailers by FSIS could weaken
public health protection by providing consumers a false sense of
security. These commenters felt that incomplete lists, even if
accompanied by an appropriate explanation, would not be helpful.
Consumers might assume that product from unlisted stores was safe to
eat, and they would not check the product information provided in the
Agency's press release in addition to the store information. Other
commenters believed that incomplete lists would force consumers to
return repeatedly to FSIS' Web site. An explanatory statement, in
itself, they stated, indicates that consumers should not place
confidence in the list when deciding what to do about recalled
products. On the other hand, commenters favoring the proposal said that
some information is better then none, and that FSIS should post the
retail consignee information, even if incomplete, along with an
appropriate explanation stating that, for example, the posting consists
of retail consignees known to date.
FSIS has concluded that the retail consignee information will
effectively complement the product information currently made available
and will be helpful to consumers in responding to the recall. While
there is always some slight potential for misinterpretation of the
retail consignee information, FSIS has also concluded that an
appropriate explanatory statement will minimize any such potential. As
discussed previously, FSIS will post an explanatory statement on its
Web site, along with the retail consignee information.
The Agency also thinks that local media outlets, including
television stations and newspapers, will publicize the names and
locations of new retail consignees as they are posted on FSIS' Web
site. FSIS will also notify relevant State officials if retail stores
in their states are identified as having received recalled product.
One commenter suggested that, as an alternative to this rulemaking,
the Agency might consider providing additional consumer education
materials that would encourage consumers to focus on available product
identification information.
While FSIS agrees that improvements in consumer education might
encourage consumers to focus on available product identification
information, improving consumer education alone will not achieve the
goals of this rule. As stated previously, the retail consignee
information will complement the product identification information that
FSIS already makes available and will provide additional opportunities
for local media outlets and State and local health officials to
transmit more targeted information about the recall to consumers. FSIS
will certainly explore additional ways to improve communication and
consumer education concerning recalls and hopes to work with industry,
consumer groups, and other stakeholders to achieve this end.
FSIS' goal in a recall is to provide the important information that
allows consumers to identify recalled product and to determine whether
that product is in their possession as effectively and quickly as
possible. FSIS has already taken several steps to assist consumers in
identifying recalled product. FSIS agrees with the commenter, for
example, that information about the frequent availability of photos of
the recalled product labels on the FSIS Web site should be promoted.
That is why each Agency press release or other information on the FSIS
Web site already includes photographs of the recalled products' labels,
if available. A fact sheet on recalls, which can be found on the
Agency's Web site at http://www.fsis.usda.gov/Fact_Sheets/FSIS_Food_Recalls/index.asp, also informs readers that FSIS includes pictures of
the recalled product as part of the online recall press release. Each
press release or RNR also informs consumers that the label bears the
establishment number inside the USDA seal of inspection and provides
the timeframe during which the recalled product was produced, another
piece of information that the commenter believes consumers would find
useful.
Some industry commenters opposing the proposal stated that retail
consignee information is protected from mandatory public disclosure by
exemption 4 of the FOIA because it is confidential business or
commercial information, and the potential value of this information
would not outweigh the competitive harm that would be caused by its
release. They pointed out that FSIS has traditionally treated a
[[Page 40943]]
company's distribution list as confidential business information.\5\
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\5\ See ``Sharing Recall Distribution Lists With State and Other
Federal Government Agencies,'' (67 FR 20009; April 24, 2002).
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The FOIA generally requires that agencies disclose records unless
the records fall within one of the FOIA exemptions from disclosure,
such as the exemption for trade secrets and commercial or financial
information found in 5 U.S.C. 552(b)(4). In this situation, an agency
must analyze whether the information constitutes privileged or
confidential commercial information within the meaning of 5 U.S.C.
552(b)(4).
FSIS, however, in considering the application of Exemption 4, has
determined that the names and locations of retail consignees of
recalled meat and poultry products compiled by the Agency do not
constitute confidential commercial information because the disclosure
of this information will not impair the Agency's ability to obtain
necessary information in the future and will not cause substantial harm
to the competitive position of any business.
As noted in the proposed rule in this proceeding, FSIS is not
releasing a firm's distribution list to the public. The Agency is also
not posting the names and locations of any of the intermediate
consignees that received recalled product or that routinely receive
product from that firm. Rather, FSIS is making public a list that FSIS
personnel compile of only the retail consignees that received recalled
product. This would be true even in those rare instances in which the
list of retail consignees includes all of the recalling establishment's
customers.
Because of the complex food distribution system in the United
States, which can include multiple wholesalers or other intermediate
distributors, it is quite possible, and perhaps likely, that the retail
consignees that ultimately sell the product to the consumer are not
customers of the federal establishment that produced the product.
Therefore, only very rarely, if ever, will the names and locations of
retail consignees expose a recalling establishment's entire customer or
distribution list. Even in such circumstances, the establishment's
customer list will not be identified as such. As a result, members of
the public and industry will not be able to determine what significance
the list has for the recalling establishment.
The disclosure of the names and locations of retail consignees of
recalled meat and poultry products compiled by the Agency is not likely
to impair FSIS's ability to obtain the names of consignees that have
received recalled product. Under the FMIA, PPIA, and the implementing
regulations that FSIS has adopted under those Acts, persons engaged in
the business of buying, selling, or transporting meat and poultry
products are required to give representatives of FSIS access to their
records.\6\ Among the records that are required to be kept are those
that provide a description of the articles sold, including the net
weight of the articles, the name and address of the buyer of the
articles sold by the person, and the name and address of the consignee
or receiver, if other than the buyer.\7\ Because retail consignees that
have received recalled meat and poultry products are engaged in the
business of buying (and selling) meat and poultry products, they must
keep various required records associated with those products, and they
must make them available to FSIS. As such, FSIS's disclosure of those
retail consignee names is not likely to impair the Agency's ability to
obtain the names of such consignees in the future.
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\6\ 21 U.S.C. 642(a), 460(b) and 9 CFR 320.1(a), 320.4,
381.175(a), 381.178
\7\ 9 CFR 320.1(b), 381.175(b).
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FSIS has also determined that disclosing the names and locations of
retail consignees that have received meat and poultry products that are
the subject of a Class I recall will not cause substantial harm to any
business. Companies have a general, affirmative interest in letting
consumers know where product is available for purchase, and they make
this information known in various ways, including company Web sites and
advertising. Thus, where the product that is the subject of a Class I
recall is branded, the company will suffer no substantial harm from the
release of retail consignee names and locations.
Even when unbranded product is the subject of a Class I recall,
there will not be substantial competitive harm from release of the
consignee list. First, the fact that the company that produced the
unbranded product is experiencing a recall is known. It is disclosed by
the Agency's press release. Second, in this situation, the name of a
supplier of unbranded product (e.g., ground beef) is of minimal to no
commercial value. Furthermore, information as to the type of product
sold in the store is readily available from its advertising or from
visiting the store.
Finally, there is no reason to believe that the retailer would
suffer substantial harm to its competitive position from the release of
its name. Many retailers post notices of recalls in their stores, and
some take affirmative steps to notify consumers of recalls by, for
example, contacting holders of customer loyalty cards who purchased the
product. This behavior is simply inconsistent with a claim of harm.
For all of these reasons, the Agency has determined that the retail
consignee information does not constitute confidential commercial
information.
FSIS does not intend to change how it compiles its lists of the
consignees to whom recalled products have been distributed as a result
of this rule, nor does it anticipate that recalling establishments will
do so either. FSIS routinely compiles consignee information when a
recall occurs, and it expects that recalling firms will continue to
make available to the Agency information on the firms to which it has
shipped the recalled products, consistent with regulatory and statutory
requirements.
Some commenters stated that the proposal may force firms recalling
product out of business because those firms' competitors will take
their retail customers during a vulnerable time period. These
commenters also stated that the rule will damage the relationship
between processors and their customers, allowing competitors to take
advantage of the situation.
FSIS disagrees. The situation described by the commenters already
arises whenever there is a meat or poultry recall. When there is a
recall, retail consignees seek to replace the recalled product as
quickly as possible. To do so, they may turn to their regular
supplier's competitor for a similar product, or they may ask their
supplier to replace the recalled product. Whether the processor-retail
consignee relationship is impaired by a recall is a function of the
nature, scope, and circumstances of the recall, not of the disclosure
of the consignee list.
FSIS recognizes that a retail consignee may be solicited by a new
supplier attempting to use a recall as a basis for gaining new
customers, and that the supplier may identify the consignee from the
posted list. No evidence has been presented in this rulemaking
proceeding, however, that the availability of a list of recall
consignees will significantly enhance the effect of those efforts. In
fact, through the years, many retail stores have made clear that they
sold product that was the subject of a recall through signs, placards,
and contacts with holders of bonus or club cards. Through these steps,
these retail stores have made clear to the public that they carried the
recalled product and thus they made themselves readily
[[Page 40944]]
identifiable to competitors of the recalling firm. Accordingly, the
Agency has concluded that there is no basis upon which to conclude that
any substantial harm will result.
A few commenters expressed concern that public interest groups may
use the retail consignee lists to encourage their members to harass or
boycott businesses involved in a recall and not to improve consumer
awareness of recalls. These commenters expressed concern that such use
could result in damage to the reputation of an establishment or its
customers.
As discussed above, many retail stores have notified their
customers and the public when they have sold recalled meat and poultry
products. Nonetheless, the commenters raising this concern did not cite
specific occurrences of retailer harassment or boycotts due to the
self-release of retailer names, nor is the Agency aware of any
situation where this information has been misused in the way suggested
by the commenters.
One commenter suggested that distributing the names and locations
of retail consignees to the public is not necessary for the proper
performance of the functions of the Agency and suggested that the
proposed rule was inconsistent with the Paperwork Reduction Act.
FSIS disagrees. This rule imposes no new information collection
requirements on the regulated industry. Under this final rule, FSIS
will continue to compile the names and locations of retail consignees
that have received recalled meat and poultry products. The only change
is that FSIS will be making this list public.
As previously noted, FSIS already requires federally-inspected
establishments and companies that engage in the business of buying or
selling meat or poultry products to maintain records that will fully
and correctly disclose all transactions involved in their businesses
subject to the FMIA and PPIA.\8\ These entities must also allow
representatives of the Secretary of Agriculture access to their places
of business so that they can examine and copy all the records.\9\
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\8\ 21 U.S.C. 642(a), 460(b) and 9 CFR 320.1, 381.175.
\9\ 21 U.S.C. 642(a), 460(b) and 9 CFR 320.4, 381.178.
---------------------------------------------------------------------------
FSIS routinely compiles information contained in these records in
carrying out its existing recall procedures.\10\ FSIS is not requiring
companies to submit any new or different information to the Agency as a
result of this rule. The burden remains on FSIS to compile and
distribute the information.
---------------------------------------------------------------------------
\10\ OMB control number 0583-0015.
---------------------------------------------------------------------------
Furthermore, sections 677 of the FMIA and 467d of the PPIA provide
that section 9 of the Federal Trade Commission Act (FTCA) (15 U.S.C.
49) is applicable to the administration and enforcement of the FMIA and
the PPIA. Under Section 9, duly authorized agents of the Secretary
have, at all reasonable times, access to, for the purpose of
examination, and the right to copy, any documentary evidence of any
person, partnership, or corporation being investigated or proceeded
against.
A few commenters stated that the proposal is not in conformity with
the Data Quality Act (DQA) because the data will not be compiled by
FSIS in a timely fashion and is not of sufficient quality because it
could be inaccurate.
FSIS disagrees with these commenters and has determined that this
rule fully complies with applicable requirements of the DQA and
relevant guidelines issued thereunder. Under this rule, accurate,
objective information will be disseminated to the public that will be
useful in helping consumers to determine if they possess recalled meat
and poultry products.
USDA's Information Quality Activities Regulatory Guidelines require
that the information disseminated by USDA agencies and offices in
conjunction with their rulemaking activities be reasonably reliable and
reasonably timely. From direct contacts with the producer and
distributors of the recalled product, FSIS compiles a list of retail
consignees that have received recalled meat and poultry products,
generally within 10 days of the initiation of the recall. It is from
these contacts that the Agency will compile, and then post on its Web
site, the listing of retail consignees that have received meat and
poultry products subject to a Class I recall. Because the contacts with
the producer and distributors are direct, FSIS has determined that the
lists of retail consignees are reliable. FSIS is committed to posting
the information in a timely fashion.
Executive Order 12866 and Regulatory Flexibility Act
This rule was reviewed by the Office of Management and Budget under
Executive Order 12866 and was determined to be significant.
FSIS, after reviewing public comments to the proposed rule,
concluded that further analysis of the costs and benefits of the rule,
and a regulatory flexibility analysis was warranted. The Agency
analyzed the potential impact of the final rule on small meat and
poultry establishments and small retail firms as part of this Final
Regulatory Flexibility Analysis. The Final Regulatory Flexibility
Analysis data is included in this final regulatory impact analysis
(FRIA) and is presented below.
This FRIA differs from the preliminary regulatory impact analysis
(PRIA) that was published for the proposed rule. First, the FRIA now
focuses only on Class I recalls. Even though this does not
significantly affect the impact analysis, FSIS has concluded that it is
prudent to modify the rule to apply only to those recalls involving
products that present the greatest risk to public health. Second, more
of the analytic information is provided so that the public can better
understand the number of recalling establishments and retailers that
are affected.
A. Need for the Rule
FSIS is taking this action to provide an additional mechanism for
prompting consumers to examine products stored in their refrigerator,
freezer, or cupboard when there is reasonable probability that the
product will cause adverse health consequences. The retail consignee
information will complement the product identification information that
FSIS already makes available and may provide additional opportunities
for local media outlets and State and local health officials to
transmit more targeted information about the recall to consumers.
B. Baseline
The baseline provides a set of conditions against which the costs
and benefits of the rule can be measured. It is important to note that
the baseline for this rulemaking takes into account that, in some
cases, Class I recalled products have not reached the retail level at
the time the recall is initiated.
1. Recall Procedures
Once an establishment agrees to recall adulterated or misbranded
meat or poultry products, FSIS widely disseminates information about
the recalled product to the public. For Class I recalls, FSIS issues a
press release to media outlets. The press release lists the names of
the states to which recalled product was shipped, if less than 13
states are affected. If the recall extends to 13 or more states, it is
considered to be a nationwide recall, and FSIS does not list the names
of the states to which the recalled product was shipped. FSIS sends
recall information to wire services and media services in the areas
where the product was distributed. In addition, FSIS sends recall
information to several
[[Page 40945]]
media and constituent list-servers. The Agency also informs or works
with affected State and local public health officials to identify
recalled products. These State and local public health officials then
further publicize the information about the recalled products.
The only change in the recall process brought about by this rule is
that FSIS will make available to the public the names and locations of
retail consignees of meat and poultry products subject to a Class I
recall, as they are identified by FSIS inspection program personnel.
2. Total Number and Size of Recalls
The total number of Class I recalls and the amount of product for
all classes recalled for 2000-2007 are shown in Table 1. The last
column shows that the majority of recalls are Class I recalls (ranging
from 63.5% to 99.9% of total recalled products), although the number
and the volume of Class 1 recalls varied from year to year.
Table 1.--Number of Class I Recalls and Volume of Class I and Total Recalls (in Pounds)
----------------------------------------------------------------------------------------------------------------
Total volume Class I as
Number of Volume class I of all classes a percent
Year of recalls class I recalls (I, II, and of total
recalls III) recalls recalls
----------------------------------------------------------------------------------------------------------------
2000.................................................... 65 21,099,672 22,743,092 92.8
2001.................................................... 61 21,230,301 33,410,564 63.5
2002.................................................... 81 56,415,558 58,911,071 95.8
2003.................................................... 45 2,288,040 3,503,689 67.0
2004.................................................... 40 2,454,558 2,882,018 85.4
2005.................................................... 48 5,940,089 6,446,149 92.5
2006.................................................... 26 4,785,669 5,947,933 80.5
2007.................................................... 50 142,885,981 143,063,822 99.9
----------------------------------------------------------------------------------------------------------------
Source: FSIS, Recall Management Staff, March 2008. Historical recall information is available at:
www.fsis.usda.gov.
3. Amount of Product Recovered
While the majority of recalls in the past eight years (2000-2007)
were Class I recalls, the recovery rate of Class I recalled products
was relatively low in six out of the eight years. The average annual
percentage of product recovered from a Class I recall was only 27.7
percent (Table 2).
Table 2.--Number of Food Product Class I Recalls: Amount Recalled, and
Recovered
------------------------------------------------------------------------
Volume of Volume
recalls (in recovered Percentage
Year million (in million recovered
lbs.) lbs.)
------------------------------------------------------------------------
2000............................ 21.1 3.37 16.0
2001............................ 21.23 4.46 21.0
2002............................ 56.42 9.20 16.3
2003............................ 2.29 0.49 20.6
2004............................ 2.45 1.43 58.4
2005............................ 5.94 4.46 74.4
2006............................ 4.79 0.66 13.8
2007............................ 142.89 1.65 1.2
------------------------------------------------------------------------
Source: FSIS, Recall Management Staff, March 2008.
4. Number of Retail Consignees
Retail consignees are defined as establishments that receive
product directly from a federally-inspected meat or poultry
establishment or through an intermediary, i.e., distributor or
wholesaler, also called an intermediate consignee. A retail consignee
sells product received in this manner to the final consumer.
Distributors or institutions that do not sell product directly to the
general public are not retail consignees. Restaurants are not retail
consignees.
The number and type of retail consignees potentially affected by
the final rule are shown in Table 3. This is a total of about 73,215
retail firms. The retail trade sector comprises facilities engaged in
retailing merchandise, generally without transformation, and rendering
services incidental to the sale of merchandise (U.S. Census Bureau,
2002 Economic Census: Retail Trade). Retailing is the final step in the
distribution of merchandise.
[[Page 40946]]
Table 3.--Retail Firms Handling Product Primarily Subject to Recall
------------------------------------------------------------------------
Number of
NAICS code Kind of business Number of small firms
firms \1\ \2\
------------------------------------------------------------------------
44511................... Supermarket and 42,318 34,638
other grocery
(except
convenience) stores.
44512................... Convenience stores.. 25,527 25,410
44521................... Meat markets........ 5,354 5,024
45291................... Warehouses and 16 3
Supercenters.
-------------------------
Total \3\........... .................... 73,215 65,075
------------------------------------------------------------------------
\1\ Source: U.S. Census Bureau, 2002 Economic Census: Retail Trade.
Establishment and Firm Size EC02-4455-52. November 2005.
\2\ Small Business Administration, Office of Advocacy. Comment to FSIS
Docket Clerk, May 4, 2006 regarding Docket No. 04-006P. Firms
comprised of supermarkets, convenience stores, and warehouse clubs are
defined as small if annual sales are less than $25 million; meat
markets are small if sales are less that $6.5 million.
\3\ This is an undercount of the number of retail firms that would be
subject to recalls because there are firms that are primarily fueling
stations or drug stores that sell relatively small quantities of milk,
bread, convenience foods, and packaged lunch meat that are not counted
by the U.S. Census Bureau.
The kinds of businesses identified as potentially subject to the
final regulation are:
44511--Supermarkets and other grocery (except convenience)
stores. These facilities sell a general line of food.
44512--Convenience stores. This industry comprises
facilities known as convenience stores or food marts (except those with
fuel pumps) primarily engaged in retailing a limited line of goods that
generally includes milk, bread, convenience foods, soda, and snacks.
445210--Meat markets. These facilities are engaged in
retailing fresh, frozen, or cured meats.
452910--Warehouse clubs and supercenters. This industry is
comprised of facilities known as warehouse clubs, superstores, or
supercenters primarily engaged in retailing a general line of groceries
in combination with general lines of new merchandise, such as apparel,
furniture, and appliances.
In addition, there are a number of retail firms that would
be subject to recalls because, while these firms primarily sell fuel or
drug stores items, a small fraction of their sales represent milk,
bread, convenience foods, and packaged lunch meat.
Most, if not all supermarkets, convenience stores, meat markets,
and warehouse clubs sell product from federally-inspected
establishments and derive a significant share of revenue from those
products. While fueling stations and drug stores sell product from
federally-inspected establishments, they derive an insignificant share
of revenue from those products. If Class I recalled products from
federally-inspected establishments were to be sold by these fueling
stations and drug stores, then their names and locations would be made
publicly available by FSIS during the relevant recall investigation
since they would be considered retail consignees that have received
Class I recalled meat and poultry products.
C. Description of Alternatives
FSIS considered several options, including amending its regulations
to include local health departments as entities that could receive
recall distribution lists or making the lists available only in
response to Freedom of Information requests and to State agencies with
agreements under 9 CFR 390.9. In addition, FSIS considered further
education of consumers, but FSIS already has education programs and
information on its Web site to inform consumers about how to identify
recalled meat and poultry products. FSIS also considered making
available to the public the names and locations of retail consignees of
both Class I and Class II recalls. However, FSIS chose to limit the
requirements of the final rule to Class I meat and poultry recalls
because Class I recalls are reasonably likely to affect the public
health, while Class II recalls are only remotely likely to affect the
public health. Furthermore, most (64 to 99.9 percent) of the recalled
products were Class I recalls (see Table 1). FSIS has adopted an
approach that will alert individual consumers, State and local
authorities, and other Federal agencies of the names of retail stores
in which the Class I recalled products may be found in as expeditious a
manner as possible.
D. Analysis of Cost
For this rule, the cost impacts for meat and poultry processors and
retail consignees are expected to be minimal.
1. Impact on Meat and Poultry Processors
This action will not impose additional significant monetary cost on
processing establishments conducting a Class I recall. FSIS
acknowledges that some products might be incorrectly returned because
they are similar to what is being recalled and are sold by the listed
retailer. However, the Agency is aware that consumers already return
products incorrectly (i.e., products not subject to recall) without
knowing the retailers associated with the recalled products. Whether
the incorrectly returned products would increase or decrease with the
implementation of this rule is an empirical question. The Agency does
anticipate that the volume of correctly returned products will increase
as this rule is intended to enhance the effectiveness of recalls.
2. Impacts on Retail Outlets
The effects of this rule on the product and financial markets for
retail facilities that receive Class I recalled product are likely to
be even less pronounced than those for the processing firms that
produce the adulterated or mislabeled product. Already, some retail
facilities, such as Wegman's, notify customers about Class I recalled
meat and poultry products. Some costs may accrue for retail consignees
as a result of increased product handling and disposal. As mentioned
before, it is not certain whether the incorrectly returned products and
the associated costs will increase or decrease as a result of this
rule.
E. Analysis of Benefits
If consumers use retail consignee information and are prompted to
identify and return Class I recalled meat and poultry products, the
recall process will be more timely and effective. Nonetheless, the
Agency acknowledges that it is difficult, if not impossible to
quantify, ex ante, the potential benefits, as one cannot predict what
kind and how many recalls will take place in the future.
[[Page 40947]]
1. Increased Opportunity to Target Information to Consumers
Information about the safety of food will cause consumers to
respond if there is a clear and relevant message, actions are advocated
that consumers can understand and accomplish, and there are continued
reminders. If consumers have access to recall information that is
meaningful, recall recovery rates can be expected to increase for Class
I recalls, given the level of risk.\11\
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\11\ The rate of recovery of recalled product could be affected
by other factors, however. The share of products affected by Class I
recalls that are raw or ground is likely higher than that for other
recall classes. Consequently, the product may move quickly through
distribution and retail channels than processed or RTE products.
---------------------------------------------------------------------------
The current recall system will be augmented by providing targeted
information to consumers about the retail destinations of products
subject to a Class I recall.
The potential value of the Class I recall information depends on
the consumer's ability to remember recent purchases of meat and poultry
products and the ability of the information to trigger in the consumer
the behavior to check whether he or she purchased the recalled product.
Consumers may be prompted to take action if they are informed that
the product was sold at the retail location where they purchase
groceries for themselves and their families. The retail consignee
information will effectively complement the product identification
information that FSIS already makes available and will provide
additional opportunities for local media outlets and State and local
health officials to transmit more targeted information about the recall
to consumers.
2. Effectiveness of Recalls
The amount of product recovered during a recall depends on many
factors. Among these factors are the amount of time taken to alert the
public after the adulterated product has been identified, the time
required by FSIS to perform recall verification activities, the type of
product being recalled (some products are consumed within days of
distribution), the amount of time the product is in distribution and
retail channels, the efficiency of recalling establishment's recall
management system, the depth into the distribution system the recall
management system operates, the number of distributors through which
the recalled product has moved, and the responsiveness of consumers to
Class I recall information.
As mentioned above, the objective of this rule is to improve the
current recall system by providing targeted information to consumers
about the retail destinations of products subject to a Class I recall.
FSIS believes this rule will have an impact on recall effectiveness
primarily through consumer responsiveness. FSIS also believes that
making information concerning retail destinations available to the
public may also influence the firms' efforts to recall their products;
however, it is difficult to predict all of the variables that could be
affected, given the differences among the various distribution channels
for meat and poultry products.
Because this rule provides an additional mechanism for prompting
consumers to examine products, FSIS has determined that posting the
list of retail consignees will enhance the effectiveness of Class I
recalls.
F. Net Benefits
There is no evidence to suggest that the impacts on retail
establishments would be significant because Class I recalled products
are typically credited to the affected retail establishment by the
processing establishment that manufactured the product.
The potential benefits of the rule hinge on the consumer being able
to use the retail consignee information in combination with the
information currently provided to identify product more quickly and
effectively than he or she does currently, so that more illnesses and
deaths can be avoided.
Based on these factors, the Agency has determined that the expected
benefits of the proposal exceed potential costs.
Final Regulatory Flexibility Analysis
The Agency analyzed the potential impact of the final rule on small
entity meat and poultry establishments and small entity retail firms
that receive product subject to a Class I recall.
The Agency's analysis of the adverse impacts of the rule on small
retail firms focuses on the increased amount of product returns retail
stores would receive in response to a Class I recall, even product that
is not subject to the recall. The number and type of small entity
retail consignees potentially affected by the final rule is shown in
Table 3. This is a total of about 65,075 small retail firms. Some costs
may accrue as a result of increased product handling and disposal. But
as mentioned above, it is not certain whether incorrectly returned
products and their associated costs will increase or decrease as a
result of this rule.
Based on the above analysis, the Agency has concluded that the rule
will not have a significant economic impact on a substantial number of
small entities.
References
1. Buzby, Jean, Paul D. Frenzen, and Barbara Rasco. 2001. ``Product
Liability and Microbial Foodborne Illnesses,'' AER-799, USDA,
Economic Research Service, Washington, DC.
2. RTI, International. June 2005. Survey of Meat and Poultry
Slaughter and Processing Plants. Final Report. RTI Project Number
08893.007. Research Triangle Park, NC 27709.
3. RTI, International. April 2006. Survey of Meat and Poultry
Processing Only Plants. Final Report. RTI Project Number
0208893.016. Research Triangle Park, NC 27709.
4. U.S. Census Bureau. 1997 Economic Census, Retail Trade. EC97R455-
SM. Issued January 2001. http://www.census.gov/prod/ec97/97r44-sm.pdf.
Paperwork Requirements
No new paperwork requirements are associated with this final rule.
FSIS is making available to the public on its Web site the names and
locations of the retail consignees of recalled meat or poultry products
that the Agency compiles in connection with its recall verification
activities.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. When this final rule is adopted: (1) All state and
local laws and regulations that are inconsistent with this rule will be
preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
E-Government Act Compliance
The Food Safety and Inspection Service is committed to complying
with the E-Government Act, to promote the use of the Internet and other
information technologies to provide increased opportunities for citizen
access to Government information and services, and for other purposes.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that
minorities, women, and persons with disabilities are aware of this
notice, FSIS will announce it online through the FSIS Web page located
at http://www.fsis.usda.gov/regulations/2008_Final Rules--Index/. FSIS
will also make copies of this Federal Register publication available
through the FSIS Constituent Update, which is used to
[[Page 40948]]
provide information regarding FSIS policies, procedures, regulations,
Federal Register notices, FSIS public meetings, and other types of
information that could affect or would be of interest to constituents
and stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. Through the Listserv and Web page, FSIS is able to provide
information to a much broader and more diverse audience. In addition,
FSIS offers an e-mail subscription service that provides automatic and
customized access to selected food safety news and information. This
service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range from recalls to export information
to regulations, directives and notices. Customers can add or delete
subscriptions themselves, and have the option to password protect their
accounts.
List of Subjects in 9 CFR Part 390
Public information.
0
For the reasons discussed in the preamble, FSIS is amending 9 CFR
Chapter III, Subchapter D, as follows:
PART 390--FREEDOM OF INFORMATION AND PUBLIC INFORMATION
0
1. The authority citation for part 390 is revised to read as follows:
Authority: 5 U.S.C. 301, 552; 21 U.S.C. 451-471, 601-695; 7 CFR
1.3, 2.7.
0
2. A new Sec. 390.10 is added to read as follows:
Sec. 390.10 Availability of Lists of Retail Consignees during Meat or
Poultry Product Recalls.
The Administrator of the Food Safety and Inspection Service will
make publicly available the names and locations of retail consignees of
recalled meat or poultry products that the Agency compiles in
connection with a recall where there is a reasonable probability that
the use of the product could cause serious adverse health consequences
or death.
Done in Washington, DC, July 11, 2008.
Alfred V. Almanza,
Administrator.
[FR Doc. E8-16221 Filed 7-16-08; 8:45 am]
BILLING CODE 3410-DM-P