[Federal Register Volume 75, Number 13 (Thursday, January 21, 2010)]
[Rules and Regulations]
[Pages 3355-3371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-873]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1115


Guidelines and Requirements for Mandatory Recall Notices

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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[[Page 3356]]

SUMMARY: The Consumer Product Safety Commission (``Commission,'' 
``CPSC,'' ``we'') is issuing a final rule establishing guidelines and 
requirements for mandatory recall notices as required by section 214 of 
the Consumer Product Safety Improvement Act of 2008 (``CPSIA''). The 
rule contains the Commission's interpretation of information which must 
appear on mandatory recall notices ordered by the Commission or a 
United States district court pursuant to certain sections of the 
Consumer Product Safety Act (``CPSA''). The rule also contains 
Commission guidelines for additional information that the Commission or 
a court may order to be included on a mandatory recall notice.

DATES: Effective Date: This rule is effective on February 22, 2010.
    Compliance Date: Regardless of when a product subject to a recall 
was manufactured, all mandatory recalls ordered pursuant to sections 
12, 15(c) or 15(d) of the CPSA are subject to the guidelines and 
requirements herein as of February 22, 2010.

FOR FURTHER INFORMATION CONTACT: Marc Schoem, Deputy Director, Office 
of Compliance and Field Operations, Consumer Product Safety Commission, 
4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7520.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of March 20, 2009 (74 FR 11883), the CPSC 
published a proposed rule that would establish guidelines and 
requirements for mandatory recall notices ordered by the Commission or 
a United States District Court under the Consumer Product Safety Act. 
The rule was intended to provide firms with a uniform set of 
information they can expect to find in a recall notice ordered by the 
Commission or a court. The Commission and a court's substantive 
authority to order that a mandatory recall notice be issued, including 
control over the final form and content of such notice, arises under 
sections 12, 15(c), and 15(d) of the CPSA. Section 214 of the CPSIA 
(Pub. L. 110-314) did not change this authority. Rather, section 214(c) 
of the CPSIA, which adds a new subsection 15(i) to the CPSA, requires 
the Commission to establish guidelines which set forth a uniform class 
of information that will be included in mandatory recall notices, and 
specifies certain content that must be included in mandatory recall 
notices. However, the Commission or a court ordering that a recall 
notice issue retains final authority over the form and content of 
mandatory recall notices. Accordingly, the Commission or a court may 
remove information that is unnecessary or inappropriate under the 
circumstances, or add additional appropriate information to a mandatory 
recall notice. Sections 15(i)(2) and 15(i)(2)(I) of the CPSA.
    The preamble to the proposed rule contained detailed explanations 
of the proposed rule and described the basis for the proposed rule. See 
74 FR 11883 through 11886. We refer readers to that preamble if they 
wish to obtain further information or explanation with regard to the 
rule. In brief, the Commission developed the proposed rule based on its 
expertise with recall notifications since the Commission's inception. 
Accordingly, the final rule is a culmination of the statutory 
requirements and the Commission's expertise, which is summarized in the 
Commission's Recall Handbook, available at http://www.cpsc.gov/BUSINFO/8002.html. Each section of the rule is either statutorily required by 
section 214 of the CPSIA, or the Commission has determined will likely 
increase recall effectiveness by helping consumers to: (a) Identify a 
product subject to a recall; (b) understand the hazard identified with 
such product; or (c) understand what remedy is being offered with 
regard to the recalled product.
    The rule does not contain requirements for voluntary recall notices 
which result from corrective action settlement agreements with 
Commission staff. If the Commission decides to extend the requirements 
to voluntary recall notices, it would proceed with a separate 
rulemaking. While this rule may serve as a general guide for 
information to include on voluntary recall notices in some instances, 
we recognize that each voluntary recall is unique and is negotiated as 
such. Therefore, all recall notices issued, whether voluntary or 
mandatory, should be tailored to the specific product and circumstances 
of a recall. Section 214 of the CPSIA did not alter the Commission's 
ability to negotiate voluntary recall notices with a manufacturer and 
to tailor both voluntary and mandatory recall notices to a particular 
recall scenario.
    The Commission received 43 substantive comments on the proposed 
rule. After reviewing the comments the CPSC made several changes to the 
rule. The changes between the proposed and the final rules are as 
follows:

              Table 1--Summary of Changes to the Final Rule
------------------------------------------------------------------------
             Proposed rule                          Final rule
------------------------------------------------------------------------
Did not contain a definition of ``Other  Defines ``Other persons'' in a
 persons''.                               new Sec.   1115.25(e). This
                                          change is discussed in more
                                          detail in response to comment
                                          12 in section III of this
                                          document below.
Provided that ``firms'' target and       Removes the word ``firm'' in
 tailor recall notices and consider the   Sec.   1115.26(a)(3) to
 manner in which a product was marketed   clarify that, in a mandatory
 and advertised in determining the form   recall scenario, firms are not
 and content of a recall notice.          the entity determining the
                                          form and content of a recall
                                          notice. By statute, the final
                                          form and content of mandatory
                                          recall notices are ordered by
                                          a United States district court
                                          or the Commission. See
                                          sections 12, 15(c) and 15(d)
                                          of the CPSA.
Did not address use of more than one     Clarifies in Sec.
 form of recall notice.                   1115.26(a)(5) that more than
                                          one form of recall notice
                                          should be used. This change is
                                          discussed in more detail in
                                          response to comments 15 and 17
                                          in section III of this
                                          document below.
Did not address when a firm has direct   Clarifies in Sec.
 contact information. Unclear whether a   1115.26(b)(2) when a firm has
 telephone number is considered direct    direct contact information.
 contact information.                     Also clarifies that a
                                          telephone number is considered
                                          direct contact information.
                                          These changes are discussed in
                                          more detail in response to
                                          comment 16 in section III of
                                          this document below.
Did not contain examples of when a       Provides examples of
 recall notice may be required in         circumstances when a recall
 languages in addition to English.        notice may be required to be
                                          made available in languages in
                                          addition to English in Sec.
                                          1115.26(c). This change is
                                          discussed in more detail in
                                          response to comment 19 in
                                          section III of this document
                                          below.

[[Page 3357]]

 
Did not clearly set forth that           Clarifies in Sec.   1115.27(c)
 information related to the product       that the information outlined
 description is required.                 therein must be included in a
                                          recall notice when applicable
                                          to a product. This change is
                                          discussed in more detail in
                                          response to comment 23 in
                                          section III of this document
                                          below.
Did not specify when a foreign           Clarifies in Sec.   1115.27(h)
 manufacturer's legal name must be        that foreign manufacturers
 identified.                              must be identified by a legal
                                          name, city, and country of
                                          headquarters. This change is
                                          discussed in more detail in
                                          response to comment 32 in
                                          section III of this document
                                          below.
Did not require a description of the     Adds ``Region'' at a new Sec.
 region where a product was sold or       1115.27(j) as a separate
 offered for sale.                        category of information which
                                          is required when necessary or
                                          appropriate to assist
                                          consumers to identify a
                                          product. This change is
                                          discussed in more detail in
                                          response to comment 21 in
                                          section III of this document
                                          below.
------------------------------------------------------------------------

II. Legal Authority

    The substantive authority for the Commission or a United States 
District Court to order that a firm issue a mandatory recall notice 
comes from existing statutes in sections 12, 15(c), and 15(d) of the 
CPSA. Section 15(c) of the CPSA specifically provides that, when the 
Commission orders that a firm conduct a mandatory recall, such order 
``shall specify the form and content of any notice required to be given 
* * *.'' Section 214 of the CPSIA does not alter the Commission's or a 
court's authority over the final form and content of a mandatory recall 
notice. Section 214(c) of the CPSIA, which added subsection 15(i) to 
the CPSA, states that the Commission shall, by rule, within 180 days of 
the date of enactment of the CPSIA (August 14, 2008), establish 
guidelines which set forth a uniform class of information to be 
included in any recall notice ordered under sections 15(c) or (d), or 
by court order pursuant to section 12 of the CPSA. (15 U.S.C. 2061, 
2064(c), or 2064(d)). Thus, the statute calls for a rulemaking which 
sets forth guidelines concerning information that firms can expect may 
be ordered in any Commission or court-ordered mandatory recall and the 
statute specifies specific content that must be included in mandatory 
recall notices.
    Section 15(i) of the CPSA states that the guidelines established by 
the Commission must include information that would help consumers: (a) 
Identify a specific product; (b) understand the identified hazard; and 
(c) understand any remedy available to the consumer. Section 15(i) of 
the CPSA also requires that a recall notice include certain specific 
information, unless the Commission determines otherwise. This 
information includes, but is not limited to, descriptions of the 
product, hazard, injuries, deaths, action being taken, and remedy; 
identification of the manufacturer and retailers; identification of 
relevant dates; and any other information the Commission deems 
appropriate.
    Finally, in addition to section 214 of the CPSIA, section 3 of the 
CPSIA grants the Commission general rulemaking authority to issue 
regulations, as necessary, to implement the CPSIA. Accordingly, the 
Commission has authority to implement section 15(i) of the CPSA, as 
amended by section 214(c) of the CPSIA, through section 3 of the CPSIA 
as well as section 214(c) of the CPSIA.

III. Comments on the Proposed Rule and the CPSC's Responses

    We describe and respond to significant issues raised by the 
comments below. To make it easier to identify comments and the 
Commission's responses, the word ``Comment'' will appear in italics 
before each comment description, and the word ``Response'' will appear 
in italics before the Commission's response. We have grouped comments 
based on their similarity and have numbered the comments to help 
distinguish between different comment themes. The number assigned to 
each comment summary is for organizational purposes and does not 
signify the comment's value, importance, or order in which it was 
received.
    Additionally, on our own initiative, we have replaced ``U.S.'' with 
``United States'' in the codified text to preclude any potential 
confusion as to what the abbreviation of ``United States'' means.

A. Comments Related to Procedural Issues

    Comment 1--Administrative Procedure Act (APA)--One commenter states 
that the NPR is lacking because it does not contain a list of data or 
studies relied upon as required by the APA. Although the preamble to 
the proposed rule states that the agency relied on agency recall 
guidance materials, including but not limited to the Recall Handbook, 
the commenter maintains that these resources were not made available to 
the general public. The commenter believes that, at minimum, 
information on where to access the resources should be provided or, a 
Web link provided for direct access to the documents. The commenter 
states that no final rule should issue until the public has the 
opportunity to review the underlying data.
    Response--The requirements for mandatory recall notices set forth 
in the proposed rule are largely dictated by section 214 of the CPSIA. 
The proposed rule also includes the Commission's interpretation and 
clarification of section 214 of the CPSIA, as well as additional 
guidelines. The preamble to the proposed rule states that, in drafting 
the proposed rule, the agency relied on its experience conducting 
recalls and recall effectiveness gained since the CPSC's inception, as 
well as agency recall guidance materials, including but not limited to 
the Recall Handbook. Contrary to the commenter's assertion that access 
to the Recall Handbook was not provided, the preamble to the proposed 
rule contained a link to the Recall Handbook (see 74 FR at 11883). 
Moreover, the Commission did not rely on quantifiable ``data'' in 
drafting the proposed rule; it relied on the text of the statute and 
more than thirty years of experience conducting recalls, which is 
summarized in the Recall Handbook. Recall templates and a recall 
checklist are also available to the public on the CPSC's Web site at 
http://www.cpsc.gov/businfo/corrective.html. These materials have been 
available to the public on the CPSC Web site long before passage of the 
CPSIA.
    Comment 2--Regulatory Flexibility Act--Two commenters take opposite 
positions with regard to applicability of the Regulatory Flexibility 
Act (``RFA'') to the proposed rule. One comment states that the RFA 
should not be applicable

[[Page 3358]]

to children's products so that small businesses will not be able to 
circumvent recall duties. Another commenter opines that the CPSC is 
attempting to evade the RFA when it states that small businesses will 
not be affected by the rule. The commenter takes this position based on 
the discretion the Commission has with regard to determining a 
``significant retailer,'' which the commenter believes, depending on 
the definition, could have a large effect on small businesses. The 
comment suggests that a small business analysis should be done on the 
proposed regulation.
    Response--The RFA generally requires that agencies review proposed 
rules for their potential economic impact on small entities, including 
small businesses. A regulatory flexibility analysis was not conducted 
pursuant to section 605(b) of the RFA, which states that the 
requirement to prepare and make available for public comment an initial 
regulatory flexibility analysis does not apply if the head of the 
agency certifies that the rule will not, if promulgated, have a 
significant economic impact on a substantial number of small entities, 
and the agency provides an explanation for that conclusion.
    As with the proposed rule, the final rule will have little to no 
effect on small businesses. First, the recall notice requirements set 
forth in the final rule are largely dictated by the CPSIA and are 
already in effect. Second, mandatory recalls are rare in the 
Commission's history, so, even if we were to assume that a significant 
economic impact would exist (and we do not claim that such an impact 
exists), the impact would not affect a ``substantial number'' of small 
entities. Third, the final rule will not alter the agency's reliance on 
voluntary recalls. Finally, the recall burden on small businesses will 
not be altered by the definition of ``significant retailer.'' The sole 
purpose of identifying retailers in the recall notice is to assist 
consumers with product identification. It has no effect on which firm 
issues a recall notice or has responsibility for conducting a recall.
    Comment 3--Effective Date--Several commenters state that because 
they believe the proposed rule seeks to impose requirements that go 
beyond the CPSIA, firms require notice of the additional requirements 
and time to comply. Accordingly, these commenters state that the rule 
should not be effective upon publication, but should follow the 
standard of becoming effective 30 days after publication so that firms 
have time to comply. One commenter suggests further that the rule be 
clarified not to apply retroactively and that the requirements only 
apply to goods manufactured after August 14, 2009.
    Response--The final rule applies only to mandatory recalls pursuant 
to a court order (section 12 of the CPSA) or an order of the Commission 
(sections 15(c), and 15(d) of the CPSA). Mandatory recalls are 
infrequent in the Commission's history, and currently there are no 
pending matters where a mandatory recall is at issue. Because of the 
length of time involved in litigating these issues in a United States 
district court or administratively, it is impracticable that any action 
would be litigated to conclusion and that an order requiring a 
mandatory recall notice would be issued in 30 days time. Therefore, 
setting the effective date 30 days after publication is appropriate and 
there is no good cause for shortening the period. Finally, the final 
rule does not go beyond the CPSIA. Section 214 of the CPSIA 
specifically provides that the Commission shall promulgate both 
guidelines and requirements for mandatory recall notices, and 
authorizes the Commission to issue additional requirements as it deems 
appropriate. Section 15(i)(2)(I) of the CPSA.

B. General Comments on the Proposed Rule and Commission Responses

    Comment 4--Many commenters seek clarification of the rule. Several 
are concerned that many requirements are unnecessary, extraneous, too 
complicated, and do not help consumers locate relevant products and 
determine what to do with them. In particular, several commenters are 
concerned about harm that could occur to business reputation based on 
the detailed requirements and the speed at which imperfect information 
may travel. Several commenters state that some information is 
burdensome for firms to maintain and report with no added benefit to 
consumers, and are concerned about the costs to maintain detailed 
records such as photographs and pricing information. These commenters 
prefer a shorter mandatory recall notice that would purportedly be more 
helpful to consumers.
    Response--Most requirements set forth in the final rule are 
statutorily mandated, and the Commission has the authority to add 
requirements it determines are appropriate. A review of the CPSC Web 
site demonstrates that the use of many of the requirements in the final 
rule in previously issued voluntary recall notices have not resulted in 
lengthy recall notices. Moreover, the final rule is not burdensome 
because it does not impose any recordkeeping requirements on firms. 
Locating a photograph of the product and the price range has not been a 
significant issue for firms at the time of a recall. Finally, the 
Commission rejects the idea that a recall notice causes undue harm to 
business reputation. Responsible firms generally desire to move quickly 
to remove defective products from the marketplace because it is 
statutorily required, preserves their brand and consumer confidence, 
limits liability, and, most importantly, reduces the likelihood of 
injuries and deaths from unsafe products.
    Comment 5--One commenter would create a mandatory recall notice 
template form that includes all required sections for a notice. The 
commenter believes that a template will be more efficient, save time 
and resources, and allow the Commission to quickly check for all 
requirements to speed approval of recall notices.
    Response--The CPSC already has a bank of recall notice examples 
that staff provides to firms to help create a recall notice. To the 
extent such a template is revised, it can and should be done outside of 
this rulemaking process, to allow both the Commission and industry 
flexibility to update such templates as appropriate.
    Comment 6--Several commenters discuss use of the words ``should'' 
and ``must'' in the proposed rule, and suggest that in the final rule, 
use of the word ``should'' should be changed to ``must'' to alleviate 
any confusion regarding the mandatory nature of the requirements.
    Response--With regard to use of the words ``should'' and ``must'' 
in the final rule generally, the statute directs the Commission to 
issue both a guidance and requirements for mandatory recall notices. 
Guidance provided by the Commission regarding mandatory recall notices 
uses the term ``should,'' while requirements are described in the 
regulation using the words ``must'' or ``shall.''
    Comment 7--One commenter notes that the rule omits timeliness 
issues with regard to issuing a mandatory recall notice. This commenter 
argues that the rule should incentivize firms to comply in a timely 
fashion, and provide penalties for non-compliance.
    Response--Timeliness is important with regard to both mandatory and 
voluntary recall notices. With regard to mandatory recall notices 
specifically, the Commission or a court will have control over the 
timing of recall notices once ordered.
    Comment 8--One commenter suggests using the civil penalties in 
section 20(a) of the CPSA as a guideline for penalties for non-
compliance with any time

[[Page 3359]]

constraints imposed. Another commenter suggests adding a section on 
prohibited acts for non-compliance with part C generally.
    Response--All prohibited acts over which the Commission has penalty 
authority are listed in section 19 of the CPSA, and the associated 
penalty amount provisions are located in section 20 of the CPSA. 
Section 19(a)(5) of the CPSA provides that it is unlawful for any 
person to ``fail to comply with an order issued under section 15(c) or 
(d).'' Accordingly, these penalty provisions already apply to mandatory 
recall orders and the Commission declines to duplicate these provisions 
in the rule.
    Comment 9--FOIA Rights--One commenter suggests that the rule 
include a section on Freedom of Information Act (``FOIA'') rights.
    Response--The Commission declines to address FOIA issues in the 
rule because a separate, pre-existing, rule on FOIA exists at 16 CFR 
part 1015.

C. Specific Comments on the Proposed Rule and Commission Responses

1. Section 1115.23--Purpose
    Proposed Sec.  1115.23 would describe the purpose for a new subpart 
C, ``Guidelines and Requirements for Mandatory Recall Notices.'' In 
accordance with direction in the CPSIA, the proposed rule would set out 
guidelines and requirements for recall notices issued under section 
15(c) and (d) or section 12 of the CPSA.
    Comment 10--One commenter believes that the proposed rule's purpose 
and reasoning section are too generic and lack specific information. 
The commenter suggests including specific rationales for why certain 
requirements will be effective and suggests adding specific examples or 
data to illustrate what the specific recall problem is and how the rule 
will address the problem.
    Response--Section 214 of the CPSIA sets forth a uniform class of 
information to be included in mandatory recall notices. The final 
rule's requirements are largely dictated by the statutory language. 
Further, the Commission's interpretation of section 214 of the CPSIA is 
not based on a scientific study, but rather on the culmination of the 
Commission's and the staff's many years of experience conducting 
product safety recalls. Because of the wide variety of consumer 
products and industries that such recalls encompass, it is necessary to 
allow flexibility to tailor recall notices to a specific target 
consumer group, product, and hazard situation to effectively remove 
hazardous products from the hands of consumers. The statute and the 
final rule give the Commission and/or a court the flexibility to add or 
remove requirements from a particular recall notice as necessary and 
appropriate, keeping in mind the goal of increasing recall 
effectiveness, and to help consumers identify products, understand the 
product hazard, and understand any available remedy.
2. Section 1115.24--Applicability
    Proposed Sec.  1115.24 would explain the requirements in subpart C 
apply to manufacturers (including importers), retailers, and 
distributors of consumer products. The preamble to the proposed rule 
(see 74 FR at 11883) explained that the rule would not contain 
requirements for recalls and recall notices that are voluntary and 
result from corrective action settlement agreements with Commission 
staff. The preamble to the proposed rule further noted that, if the 
Commission decides to extend the requirements to voluntary recalls, it 
would proceed with a separate rulemaking initiated by a separate notice 
of proposed rulemaking.
    Comment 11--Many commenters note the Commission's statement that 
the proposed rule will apply to mandatory recall notices only and will 
serve as a guideline for voluntary recalls unless and until the 
Commission initiates a separate rulemaking to apply the requirements to 
voluntary recalls.
    Comments from individuals and consumer groups generally support the 
extension of the mandatory notice requirements to voluntary recalls to 
promote uniformity and consistency in providing consumers recall data 
and to prevent firms from circumventing the requirements for a 
mandatory recall notice by agreeing to a voluntary recall. One 
commenter notes that voluntary recalls comprise the vast majority of 
recalls and that the protections and information afforded by the 
mandatory recall notice should be extended to consumers in voluntary 
recall notices as well. Some commenters believe that consumer safety is 
compromised by not using the same notice requirements for both 
mandatory and voluntary recalls. One commenter states that the 
mandatory recall notice requirements should at least be applied to 
voluntary recall notices for ultrahazardous products.
    Industry commenters are generally opposed to extending the 
mandatory recall notice requirements to voluntary recall notices, 
arguing that important differences exist between a mandatory and 
voluntary recall. For example, one commenter states that, during a 
voluntary recall, the firm and the CPSC staff have time to develop an 
effective recall notice in a more positive environment. Depending on 
the nature of the product and the harm, the same level of detail may 
not be necessary for every recall to be helpful to consumers. These 
commenters support the current system whereby the final notice 
requirements are left for each specific recall situation working with 
the staff. One commenter notes the success of the Fast Track program 
and believes the Commission should continue to foster cooperation in 
that program and only impose mandatory recall procedures when 
absolutely required. Some commenters state that imposing mandatory 
notice requirements will discourage firms from conducting voluntary 
recalls, which is typically done to avoid the burdens of a mandatory 
recall. Less voluntary recalls will lead to over-burdening the 
Commission staff and resources.
    A few commenters are concerned about the mandatory notice 
requirements even serving as a guideline for a voluntary recall notice 
and urge the Commission to withdraw this statement. One commenter 
believes that a heightened level of importance should be associated 
with mandatory recalls. Other commenters note that, even though the 
Commission acknowledges that a separate rulemaking will be necessary to 
extend the requirements to voluntary recalls, using the rule as a 
guideline is essentially a distinction without a difference. One 
commenter suggests that the Commission explicitly acknowledge in the 
preamble that a voluntary recall notice will not need to meet all of 
the guidelines for a mandatory recall notice in order to be approved 
for voluntary corrective action.
    Response--While the Commission may use the mandatory recall 
requirements as a general guide for voluntary recall notices, we 
recognize that a separate rule on voluntary recall notices is needed to 
make these requirements uniform and required. The ultimate purpose of 
every recall notice is to get dangerous products out of the hands of 
consumers as quickly as possible, and each recall notice must be 
negotiated with that goal in mind. The Commission still retains the 
flexibility to work with firms to tailor voluntary recall notices to a 
particular product and particular recall circumstance.
3. Section 1115.25--Definitions
    Proposed Sec.  1115.25 would define ``recall,'' ``recall notice,'' 
``direct recall notice,'' and ``firm.''
    Comment 12--One commenter suggests that the final rule define 
``other

[[Page 3360]]

persons,'' who were mentioned in proposed Sec.  1115.26. The preamble 
to the proposed rule explained that ``the term `other persons' would 
include, but would not be limited to, consumer safety advocacy 
organizations, public interest groups, trade associations, other State, 
local and Federal government agencies, and the media.'' 74 FR at 11884. 
Another commenter states that it is important to keep ``other persons'' 
in the rule to acknowledge that both governmental and non-governmental 
entities are involved in the dissemination of information in the 
interest of consumer safety.
    Response--The Commission agrees that defining ``other persons'' in 
the rule acknowledges the importance that both governmental and non-
governmental entities can play in the broad dissemination of consumer 
product safety information. Accordingly, the final rule adds the 
definition of ``other persons'' at Sec.  1115.25(e) as follows: ``Other 
persons means, but is not limited to, consumer safety advocacy 
organizations, public interest groups, trade associations, industry 
advocacy organizations, other State, local, and Federal government 
agencies, and the media.'' This definition is the same as set forth in 
the preamble to the proposed rule, with the addition of ``industry 
advocacy organizations,'' to demonstrate the broad range of entities 
that assist in disseminating product safety information.
4. Section 1115.26--Guidelines and Policies
    Proposed Sec.  1115.26 provides general guidance and describes the 
policies pertaining to recall notices. The proposed guidelines would 
restate the goals delineated in section 214 of the CPSIA. The CPSIA 
requires the guidelines to include information helpful to consumers.
    In general, proposed Sec.  1115.26(a) would state general 
principles that are important for recall notices to be effective. For 
example, proposed Sec.  1115.26(a)(1) would state that a recall notice 
should provide information that enables consumers and other persons to 
identify the product and take a stated action. Proposed Sec.  
1115.26(a)(2) through (a)(4) would provide guidance on the form of the 
recall notice, recognizing the various forms of notice and providing 
guidance concerning direct recall notices and Web site recall notices. 
Proposed Sec.  1115.26(a)(4) would recognize that a direct recall 
notice is the most effective form of a recall notice, and proposed 
Sec.  1115.26(b)(2) would state that when firms have contact 
information they should issue direct recall notices.
    Comment 13--Many comments discuss Sec.  1115.26(b)(2) on direct 
recall notices and Sec.  1115.26(a)(4) which states that direct recall 
notices are the most effective form of a recall notice. Overall, 
individual consumer comments support the proposed rule with regard to 
direct recall notices, suggesting that consumers tend to tune out 
information not directed to them. One commenter notes that direct 
recall notices have worked effectively in Illinois since 2006. A few 
commenters suggest revising the rule to require firms to exhaust 
resources and to send direct recall notices via every means possible 
depending on the data they have, i.e., mail, electronic mail, and via 
telephone. One commenter suggests requiring e-mail notification when a 
firm has e-mail contact information. One commenter suggests asking 
consumers to forward e-mail notices to people they know have an 
interest in receiving the information in order to take advantage of 
social networking abilities. However, another commenter suggests that, 
because people ignore e-mails based on the large volume received, 
direct regular mail notices and automated phone messages would be more 
effective. Another commenter suggests that a direct recall notice be 
required in all cases where a firm has contact information unless the 
firm can prove by a preponderance of evidence that a direct recall 
notice will not be as effective as other forms of a recall notice.
    However, one commenter urges that direct recall notices should only 
be required when a significant and imminent health and safety risk is 
involved because of the costs involved in direct notice and because 
over-warning can de-sensitize consumers. Moreover, section 15 of the 
CPSA recognizes that the form of notice depends on the risk involved 
and affords parties the opportunity for a hearing before the Commission 
can order a number of actions.
    Response--Direct recall notices are the most effective form of a 
recall notice. 74 FR at 11886. The statement is based on the 
Commission's experience that one of the most important aspects of 
conducting a recall is to target recall notices to those consumers that 
are more likely to have purchased the product at issue. Direct recall 
notices have the advantage of reaching a large portion of the consuming 
public that may have actually purchased the product. Even if the 
product was not ultimately used by the purchaser, in the case of a 
parent buying a product for a child or a consumer buying a gift, the 
purchaser is in a good position to notify the product's user about the 
recall. Ensuring that notice of the recall is provided in a timely 
manner to the affected target audience is a major component of recall 
effectiveness, and direct recall notices are a key advantage in the 
recall process when this information is known. Moreover, the rule 
recommends, but does not require, use of direct recall notices. 
Assessing whether direct notice is necessary, appropriate, or possible 
in a particular mandatory recall is best done on an individual basis.
    Comment 14--One commenter advocates a clear delineation in the rule 
with regard to responsibility for direct recall notices. This commenter 
argues that manufacturers should never have responsibility for a direct 
recall notice, but should have responsibility for broad dissemination 
through other means. Direct notice responsibility should fall to the 
product distributors and retailers that have such contact information.
    Response--Determining which firms have responsibility for a recall 
and disseminating recall notices is beyond the scope of the rule, which 
solely relates to information categories required on a mandatory recall 
notice.
    Comment 15--Some commenters note the limitations of relying solely 
on direct recall notices. One commenter states that direct recall 
notices are not the best method of notifying consumers, and should 
never be used as the sole method of notifying consumers because they 
miss third party consumers that purchase products second-hand or 
receive them as gifts. Considering the popularity of certain Web sites 
that sell, re-sell, or auction consumer products, direct recall notices 
could miss a large population of the consuming public. Additionally, 
the general public has an interest in knowing about recalled products, 
such that the recall strategy should be to reach the broadest possible 
audience.
    Response--The Commission agrees that a direct recall notice should 
not be the sole form of recall notification because the purpose of a 
recall notice is to reach the broadest possible audience of consumers 
that may have purchased or received the products. Sole reliance on 
direct recall notices ignores the fact that other persons may benefit 
from receiving recall notices and assist in broad dissemination of 
recall notices. The final rule acknowledges this by adding Sec.  
1115.26(a)(5) stating that at least two of the recall notice forms 
listed in subsection (b) should be used.
    Comment 16--One commenter asks the Commission to clarify the rule 
with regard to the factors for determining

[[Page 3361]]

when a firm actually has direct contact information. This commenter 
states that firms have millions of bits of information, but being able 
to track the information to a specific time frame and product is time 
consuming and costly. Moreover, firms may have some information related 
to the sale, i.e., credit card information, but may not have all 
information without relying on a third party to match data, which can 
also be time consuming and costly. The commenter urges that the rule 
clarify that it only applies when accurate, up to date, contact 
information is readily and practically available, and is in fact in the 
firm's direct possession. Another commenter suggests adding ``telephone 
number'' to the list of contact information, and to prioritize the 
direct notice methods as follows: (1) Direct mail; (2) e-mail; and (3) 
telephone.
    Response--Assessing when a firm has possession of direct contact 
information and when the information should be used is best done on an 
individual basis because of the variety of information that firms or 
third parties may possess. However, the final rule clarifies that ``[a] 
direct recall notice should be used for each consumer for whom a firm 
has direct contact information, or when such information is obtainable, 
regardless of whether the information was collected for product 
registration, sales records, catalog orders, billing records, marketing 
purposes, warranty information, loyal purchaser clubs, or other such 
purposes.'' The Commission or a court retains flexibility to determine 
when a firm has direct contact information and when a direct recall 
notice is appropriate. The final rule also clarifies that a telephone 
number is considered direct contact information: ``[D]irect contact 
information includes, but is not limited to, name and address, 
telephone number, and electronic mail address.''
    Comment 17--Some commenters are positive about the various methods 
available for dissemination of information, but want the Commission to 
make more than one form of notice mandatory. For example, one commenter 
would require multiple forms of dissemination so that firms cannot rely 
on a single press release and notice to retailers. Another commenter 
suggests requiring firms to contact national and local media. Another 
commenter is concerned that the rule does not require firms to ensure 
that notices are actually received and not dismissed as spam or junk 
mail and says requiring multiple dissemination methods would address 
this problem. Several commenters would require the use of paid 
advertisements, for example, where injuries and deaths have occurred. 
Similarly, another commenter suggests that the recall notice be 
required to be disseminated in the same manner as advertising and 
promotion for the product.
    Response--Section 1115.26(a)(5) in the final rule provides that 
more than one form of recall notice should be used. The Commission 
declines to provide for any certain type of notice for every recall in 
the final rule. Recall notice forms may vary depending on the type of 
hazard, the severity of the risk, and the nature and distribution of 
the target audience. While circumstances will arise where paid 
advertisements are warranted and the Commission's or a court's order 
may require their use directed to certain target audiences, in certain 
time frames and intervals, retaining flexibility and creativity to 
adjust the forms of required recall notices to the specifics of each 
case and to allow for technological advancements in recall notice forms 
should be maintained.
    Comment 18--Several comments support Sec.  1115.26(b)(3), stating 
that a Web site recall notice should be prominent and clear on the 
first entry point of a Web site, such as a home page, and be 
interactive. Several commenters suggest making a Web site recall notice 
a mandatory requirement when a firm maintains a Web site. One commenter 
agrees that the information must be on the home page and urges the CPSC 
not to allow firms to bury recall notices deep within a Web site. These 
commenters support the idea of an interactive Web site that allows a 
consumer to seek a remedy on-line.
    However, one commenter opposes placing a recall notice on a firm's 
home page and states that such a requirement goes beyond the CPSIA 
mandate. This commenter argues that manufacturers and distributors post 
Web site recall notices in a location where consumers have become 
familiar with locating the information. This commenter urges that the 
CPSC should not adopt a ``one-size fits all'' home page requirement and 
that the decision should be based on the circumstances of each case. 
Moreover, the requirement for an interactive Web site which allows a 
consumer to request a remedy does not make sense in all cases. The 
commenter gives the example of ATVs and RVs, which must be taken into 
an independent dealer for repair. Because section 214 of the CPSIA does 
not require an interactive Web site, the commenter would delete this 
section from the final rule.
    Response--The Commission agrees that product safety information 
should not be buried in a firm's Web site. Since at least 2000, the 
CPSC has provided guidance to firms to post recall notices prominently 
on the home page of the firm's Web site. The Commission rejects the 
proposition that the rule goes beyond the requirements of the CPSIA 
with regard to providing an interactive Web site for recalls. First, 
the guidelines and policies set forth in section 1115.26 of the final 
rule are guidelines, not requirements. And, as reviewed above, section 
214 of the CPSIA specifically provides that the Commission should 
``include any information that the Commission determines would be 
helpful to consumers'' to identify the product, understand the hazard, 
and understand the proposed remedy. Although, for example, an ATV 
cannot be exchanged through a Web site, a prominently placed Web site 
recall notice that is interactive will expand the recall notice to the 
relevant target audience, and increase recall effectiveness by helping 
consumers with product identification, hazard identification and to 
understand the nature of the remedy being offered. Moreover, if the 
remedy is a repair, an interactive Web site can help consumers to 
locate a dealer to make the necessary repair and/or arrange an 
appointment for such repair at an appropriate dealer. While the content 
and nature of Web site interactivity may be product and remedy 
specific, the tool itself can be used in many ways to enhance consumer 
understanding and recall effectiveness.
    Comment 19--Comments generally support Sec.  1115.26(c), which 
states that the Commission or a court may require that a recall notice 
be in languages in addition to English ``when necessary or appropriate 
to adequately inform and protect the public,'' but would set mandatory 
criteria for recall notices in additional languages. For example, one 
commenter states that the phrase ``necessary and appropriate'' requires 
further clarification and an explanation of the criteria that will be 
used. Another commenter urges the Commission to consider languages 
likely used by consumers when reviewing and approving recall notices 
and to insure that recall hotlines and on-line forms should be made 
available in additional languages when the product was likely purchased 
by non-English speaking consumers.
    Several commenters note the current demographic situation in the 
United States, stating that approximately 12% of the population speaks 
Spanish, and suggest that the Commission require that all recall 
notices be drafted in both English and Spanish. Another commenter 
suggests requiring that all

[[Page 3362]]

recall notices be drafted in the top two or three other languages 
spoken in the United States.
    Moreover, several commenters opine that the rule should contain 
criteria to help determine when recall notices in additional languages 
should be required. Suggestions for criteria for a mandatory language 
requirement include:
     When product labeling is primarily in a language other 
than English;
     When product instructions are written in more than one 
language; and
     When a product is marketed in a language other than 
English.
    Finally, one commenter suggests that the Commission maintain a 
``bank'' of standard recall information in other major languages spoken 
in the United States to help reduce the costs of providing recall 
notices in additional languages.
    Response--The final rule clarifies when the Commission or a court 
may order that a recall notice be made in languages in addition to 
English by providing non-exhaustive examples. However, the Commission 
and/or a court retain flexibility to tailor recall notices to 
individual recall circumstances. Two criteria suggested by commenters 
have been added as examples in the final rule: When the product 
labeling is primarily in a language other than English and when a 
product is marketed in a language other than English. Both examples 
establish circumstances where it may be necessary or appropriate to 
issue recall notices in additional languages in order to increase the 
likelihood that audiences will understand the notices. The final rule, 
at Sec.  1115.26(c), states one additional example: When a product is 
marketed or available in a geographic area where English is not the 
predominant language. This example demonstrates that even when a 
product's marketing or labeling is in English, there may be 
circumstances that arise in a mandatory recall scenario that still make 
it appropriate to distribute recall notices in languages in addition to 
English.
    The Commission declines to adopt additional criteria in the final 
rule that would not result in an efficient use of staff resources. For 
example, insufficient information exists to impose a requirement that 
every mandatory recall notice be made available in two or three 
languages. Finally, maintaining a ``bank'' of standard recall 
information in other languages is something the Commission may consider 
doing as a matter of efficiency, but it is not within the scope of the 
rule.
5. Section 1115.27--Recall Notice Content Requirements
    Proposed Sec.  1115.27 would set forth the recall notice content 
requirements specified in the CPSIA and would provide further details 
where appropriate. For example, proposed Sec.  1115.27(a) would require 
that a recall notice include the word ``recall'' in the heading and 
text. As another example, proposed Sec.  1115.27(b) would require the 
recall notice to contain the date of its release, issuance, posting, or 
publication.
    Comment 20--One commenter would have the rule address the sequence 
of information found in a mandatory recall notice. The commenter would 
have the most important information appear at the top of the notice 
because it is more likely to be read. For example, the photograph of 
the product should appear at the top of the notice under the ``recall'' 
heading. The commenter would use the following order: Description of 
product hazard, type of hazard or risk, identification of retailers, 
etc. This commenter also suggests that the rule address readability 
issues, such as the use of bullet points over lengthy paragraphs.
    Response--The Commission agrees that recall notices should be 
written with the intent to aid readability and understanding by 
consumers, but that this issue is best addressed on an individual, 
case-by-case basis. In a mandatory recall situation, the Commission or 
a court has control over the final form and content of a recall notice, 
and can require such notices to conform to the standard format already 
in use. The Commission declines to set a uniform sequence in the 
current rulemaking because what represents the most critical recall 
information may vary slightly depending on the circumstances 
surrounding the recall.
    Comment 21--One commenter suggests adding a ``Region'' provision to 
mandatory recall notices to specify the geographic region in which the 
product was made available in order to narrow down areas of concern 
when a national retailer is involved. This commenter suggests that the 
``Region'' should state whether the product was for sale on line, so 
that a consumer understands when the geographic area may have been 
broadened by Internet sales.
    Response--When it is relevant, a specific geographic region where a 
product is sold or offered for sale is typically included in a recall 
notice. Although the proposed rule did not list ``region'' as part of 
the recall notice content requirements, adding a separate ``region'' 
requirement to a mandatory recall notice could help to narrow the 
geographic range for affected retailers and consumers (while not 
narrowing the range for dissemination of a recall notice generally), 
and would allow for a description of the region in situations where no 
significant retailer is identified. Designation of a region may help 
consumers to identify whether they have the product being recalled. 
Accordingly, the final rule adds a requirement for ``Region'' as a new 
Sec.  1115.27(j), which provides that ``[w]here necessary or 
appropriate to assist consumers in determining whether they have the 
product at issue, a description of the region where the product was 
sold, or held for purposes of sale or distribution in commerce, must be 
provided'' and has renumbered the remaining paragraphs accordingly.
    Comment 22--Most commenters support Sec.  1115.27(a)'s requirement 
to use the word ``recall'' in the heading and text of the notice. A few 
commenters suggest use of the label ``Safety Recall'' in the heading to 
alert consumers to a safety issue with regard to the product. One 
commenter suggests using the term ``Urgent Recall'' in the heading 
whenever there is a serious risk of death or loss of limb. This 
commenter urges that the Commission use this designation to create a 
more serious class of product recalls.
    One commenter dislikes using the word ``recall'' in every notice, 
arguing that it may be misleading and ``unnecessarily harmful to the 
character of a product, manufacturer, importer, or retailer'' by 
suggesting the harm is greater than it actually may be. This commenter 
suggests using language from the ``action taken'' section, which the 
commenter believes will be more accurate in describing the nature of 
the recall at issue. At minimum, the commenter suggests using 
``recall'' along with the ``action taken'' in the header so that 
consumers can quickly and easily see the nature of the action being 
taken with regard to the product.
    Response--As a matter of Commission policy for consistency and 
uniformity, use of the word ``recall'' is preferred because consumers 
and other persons recognize the word ``recall'' as meaning that a 
safety issue has arisen that requires action by the consumer. The 
CPSC's position on the title of a recall notice has been in the Recall 
Handbook for many years. The Commission does not agree that the 
dissemination of a recall notice necessarily harms manufacturers. As 
reviewed in the Recall Handbook, consumers no longer necessarily view 
product recalls in a negative light and are, instead, more likely to 
have a

[[Page 3363]]

negative view of a firm if it does not take responsibility for 
conducting an effective recall. How well a company conducts a timely, 
reasonable recall of a product may have a strong influence on 
consumers' attitudes about the firm. Successful product recalls can 
result in continuing consumer support and demand for the firm's 
products.
    While the Commission categorizes recalls, as set forth in the 
Recall Handbook Section III, CPSC Evaluation of Section 15 Reports, the 
Commission has avoided categorizing recall notices because it wants 
consumers to review and respond to all recall notices. Consumers should 
have the opportunity to read each notice and make an informed decision 
regarding whether they have the product, whether the risk of injury 
applies to them, how to avoid injury, and how to take advantage of any 
remedy associated with the recall. Categorizing recalls by the severity 
of risk may hinder the overall goal of recall effectiveness.
    Comment 23--A few commenters agree with proposed Sec.  1115.27(c)'s 
requirements pertaining to a description of the product. However, one 
commenter suggests that it is unclear whether Sec.  1115.27(c)(1) 
through (6) establishes requirements because the word ``must'' is not 
used. This commenter suggests clarifying the rule so that firms know 
whether all or some subset of these product identification guidelines 
are required.
    Response--Section 15(i)(2) of the CPSA requires that a mandatory 
recall notice include a product description, including model numbers or 
SKUs, common product name(s), and a photograph of the product. The 
final rule is organized such that items in Sec.  1115.26 are guidelines 
and policies, and items in Sec.  1115.27 are requirements. Accordingly, 
Sec.  1115.27(c) provides that ``[a] recall notice must include a clear 
and concise statement of the information that will enable consumers and 
other persons to readily and accurately identify the specific product 
and distinguish it from similar products. The information must enable 
consumers to readily determine whether or not they have, or may be 
exposed to, the product.'' The rule lists six types of descriptive 
information relevant to product identification, including the fact that 
a photograph ``must'' be included. The final rule clarifies that when 
the information specified under this section is applicable to a 
particular product, it must be included as part of the product 
description: ``[T]o the extent applicable to a product, descriptive 
information that must appear on a recall notice includes, but is not 
limited to:'' The list is not exhaustive, however, and additional 
product identification information may be required for a particular 
recall notice.
    Comment 24--Several comments would strengthen the remedy 
requirements in proposed Sec. Sec.  1115.27(d) and (m). One commenter 
observes that the remedy offered must be implementable by all parties. 
The commenter notes that there have been several instances where a 
manufacturer offered a remedy, such as a voucher or coupon, that was 
not recognized by all retailers' computer systems when presented by a 
consumer. Accordingly, consideration of different systems should be 
given when providing a remedy and approval by the CPSC.
    A few commenters suggest limiting a manufacturer's ability to 
instruct consumers to discard products. They argue that this remedy 
should be limited to situations where a firm has gone out of business 
or the product is of nominal value. One commenter urges the Commission 
to not approve any recall notice that does not include replacement, 
repair, or refund of the purchase price as a remedy because consumers 
will be less likely to comply without compensation as they do not want 
to pay for the item twice. Finally, one commenter urges the Commission 
to include a section for ``incentive'' or ``reward'' to inform 
consumers about any additional incentives for the return of the 
product, or state that ``none'' are being given.
    Response--The nature of remedies approved as part of a corrective 
action plan goes to the substance of a corrective action plan, which is 
not at issue in the final rule. With regard to the suggestion to 
include a category for a description of any recall incentive in a 
mandatory recall notice, while the Commission generally encourages 
firms to offer incentives for compliance with a recall, the Commission 
declines to require a separate category for such information. 
Incentives are properly part of the remedy being offered. An additional 
category for incentives in every recall notice, even when an incentive 
is not being offered, will lengthen the recall notice without improving 
the overall effectiveness of the notice or providing new or different 
information to help consumers understand the remedy being offered.
    The Commission also notes that proposed Sec.  1115.27(m) is now 
renumbered as Sec.  1115.27(n) in the final rule.
    Comment 25--Proposed Sec.  1115.27(e) would require the recall 
notice to state the approximate number of product units covered by the 
recall, including all product units manufactured, imported, and/or 
distributed in commerce. Several comments suggest clarifying Sec.  
1115.27(e) by requiring a statement of the number of product units 
included in a recall notice. A few commenters state that the rule 
should only include products actually sold to consumers so that the 
number does not include products that were never sold to any 
distributor or retailer or are still in the hands of the manufacturer 
and were never imported. The commenters believe that these products are 
not subject to a recall and that it is inappropriate and beyond the 
scope of the CPSIA to include in the number of units products that have 
never been in the hands of consumers. Moreover, these commenters argue 
that including such data is misleading and distorting of the number of 
products actually subject to the recall and cannot be said to help 
consumers identify a product, understand a product hazard, or obtain a 
remedy.
    One commenter suggests that product unit information is 
unnecessary, unhelpful to the consumer, and is likely to overwhelm the 
average consumer. According to this commenter, including product unit 
information only serves to frustrate the purpose of understanding the 
product's actual or potential hazard. This information could have a 
negative effect on the firm, and media and other groups could 
incorrectly focus on the number of products being recalled rather than 
any actual threat of public harm.
    Response--Section 15(i)(2)(C) of the CPSA requires that a mandatory 
recall notice include ``[t]he number of units of the product with 
respect to which the action is being taken.'' Accordingly, firms must 
state product unit information in a mandatory recall notice pursuant to 
the statute. The Commission's interpretation of this section of the 
statute is consistent with past Commission practice for all recall 
notices, as set forth in the Recall Handbook, which is to list all 
units of a product manufactured, imported, and/or distributed in 
commerce. As for those comments suggesting that products that are not 
in the hands of consumers are not subject to a recall, the CPSC has 
jurisdiction over all consumer products subject to a recall, and all 
such products must be dealt with in a corrective action plan, 
regardless of where the product is in the supply chain. For example, in 
a mandatory recall situation, a manufacturer holding product could not 
sell, modify, or destroy product without CPSC authorization. Stating 
the number of product units involved informs consumers as to the scope 
of a recall,

[[Page 3364]]

aids product identification, and increases recall effectiveness.
    Comment 26--Many comments address proposed Sec. Sec.  1115.27(f) 
and (l) regarding a description of substantial product hazard and a 
description of the incidents, injuries and deaths. Several commenters 
agree that requiring a mandatory recall notice to describe and state 
the number of injuries and deaths is helpful to consumers and will 
motivate them to comply with the recall. Many commenters, however, 
state that specific information on injuries and deaths is unnecessary 
and irrelevant, or suggest that the rule should be further clarified to 
prevent the recall notice from becoming a lengthy, multi-paged 
document. One commenter states that proposed Sec.  1115.27(f) exceeds 
the scope of the intent of the CPSIA with regard to a description of 
the substantial product hazard and reason for action. This information 
may not be feasible for firms to provide and may be more misleading 
than informative because a firm may not know all of this information at 
the time of a recall. Further, several commenters state that reporting 
death statistics is outside the purpose of a recall, will not help 
consumers or their decision to participate in a recall, but will have 
an adverse effect on retailers and producers.
    Response--Sections 15(i)(2)(D) and (G) of the CPSA require that a 
mandatory recall notice include ``[a] description of the substantial 
product hazard and the reasons for the action,'' as well as ``[t]he 
number and a description of any injuries or deaths associated with the 
product, the ages of any individuals injured or killed, and the dates 
on which the Commission received information about such injuries or 
deaths.'' Accordingly, the statute and the final rule require both a 
description of the substantial product hazard and specific information 
on injuries and deaths, including the number, description and ages of 
persons involved. However, recall notices will, by necessity, only 
include information regarding a substantial product hazard and any 
injuries or deaths that are known at the time of the recall notice.
    The Commission also notes that it has renumbered Sec.  1115.27(l) 
as Sec.  1115.27(m) in the final rule.
    Comment 27--Some commenters request clarification on what 
constitutes an injury that requires reporting, what the phrase 
``associated with the product'' in proposed Sec.  1115.27(f) means, 
what ``product conditions or circumstances'' can give rise to an injury 
or death related to a product, and what a ``concise summary'' 
constitutes. For example, one commenter opines that the term ``injury'' 
should be defined to only include injuries which require medical 
treatment, and to exclude minor injuries such as superficial scrapes 
and bruises. This commenter states that defining ``injury'' will make 
reporting consistent across recall notices. Another commenter states 
that ``associated with the product'' language could be interpreted 
broadly to require that all deaths or injuries be reported, even when 
there may be other causes, such as gross negligence or use contrary to 
warning labels. One commenter suggests that the rule address whether a 
manufacturer must list any death or injury, however tangential, or may 
qualify injuries where gross negligence and contrary use are involved. 
Finally, one commenter believes that requiring detailed information on 
injuries and deaths will expose firms to liability for acts that have 
not been proven in court to be causally linked to the products without 
providing any benefits to the consumer. Moreover, it could require 
corporations to implicate themselves criminally or civilly, in 
violation of the Fifth Amendment of the Constitution.
    Response--With regard to the types of injuries required to be 
reported on a recall notice, the Commission interprets the statutory 
requirement consistent with past agency practice with regard to 
reporting injuries on a recall notice, which is to include all 
injuries, regardless of whether a consumer sought medical treatment, 
where the consumer product is present at the time of the injury and may 
have been a contributing factor.
    A well-crafted recall notice does not necessarily subject a firm to 
increased product liability. The Commission's mandate is public safety, 
and effective recall notices can play an important role in enhancing 
public safety. Allowing a defective product to stay on the market 
without providing the public with timely hazard and recall information 
would likely result in increased liability for non-compliant firms, not 
only from potential civil and criminal penalties by the Commission, but 
from product liability lawsuits as well. Finally, no concern exists 
that providing information on injuries and deaths in a recall notice 
impairs any Fifth Amendment right against self-incrimination, as the 
Fifth Amendment protects individuals, not corporate entities. See, 
e.g., Bellis v. United States, 417 U.S. 85, 88-90 (1974) (reviewing 
history of decisions regarding the Fifth Amendment privilege and its 
inapplicability to corporations and stating that no artificial 
organization may utilize the personal privilege against self-
incrimination to avoid producing corporate documents).
    Comment 28--Several comments would clarify the rule to allow 
reporting of injuries and age ranges in the aggregate. These commenters 
argue that reporting specific ages is not necessarily helpful for the 
consumer to evaluate the risks involved. Moreover, if the rule is 
interpreted to require a description of each injury and the age of each 
person, this could turn the recall notice into a lengthy, multi-page 
document that defeats the purpose of efficiently and effectively 
identifying the product, explaining the hazard, and communicating a 
remedy to consumers. Age ranges can be described in numbered ranges, 
or, for example, as adult, child, infant. One commenter opines that the 
number of injuries is not as important as the details of the injuries 
and deaths, to distinguish minor injuries from other types of harm.
    Response--Reporting of injuries and deaths, including the ages of 
individuals injured or killed, is statutorily required in a mandatory 
recall notice. Providing this information, however, need not result in 
a lengthy recall notice. Consumers and firms can find numerous examples 
of recall notices on the CPSC's Web site, and note that when age and 
injury information is detailed, it does not result in lengthy, 
unreadable recall notices. The Commission or a court retains the 
flexibility to craft effective recall notices for particular recall 
scenarios which are in the best interest of the consumer. The exact 
wording of any recall notice cannot be done before the fact, and the 
Commission declines to adopt a specific, one size fits all, approach to 
how this information is presented for every recall notice. Firms should 
anticipate that aggregation of age information will be required in 
limited circumstances.
    Comment 29--One commenter states that information regarding 
injuries on exact dates can be considered confidential material 
supplied to staff under section 15(b) of the CPSA. Including such 
information in a recall notice would undermine confidentiality under 
section 6(b) of the CPSA and otherwise. Another commenter notes that 
the date of injury may be unrelated to when the consumer decides to 
report the injury and how accurately the injury is characterized. One 
commenter states that if the information must be provided, then the 
Commission should at least allow firms to provide a range of dates 
rather than exact dates, or a summary such as ``prior to the time of 
this announcement.'' Another

[[Page 3365]]

commenter, however, agrees that the recall notices should include the 
dates or date ranges when the Commission received information about 
deaths or injuries, and suggests that the Commission further require 
the dates or date ranges when the recalling firm received information 
about deaths or injuries.
    Response--Some commenters may misunderstand the statutory 
requirement with regard to reporting dates related to injuries. Neither 
the statute nor the rule require that a mandatory recall notice state 
the actual date that an injury or death occurred, or the actual date 
when a firm received information about an injury. Section 15(i)(2)(G) 
of the CPSA requires that a mandatory recall notice include ``the dates 
on which the Commission received information about such injuries or 
deaths.'' (Emphasis added.) At minimum, a month and year must be 
reported as to when the Commission received such information. 
Accordingly, aggregation of the month and year may occur when necessary 
or appropriate to shorten the information presented on a recall notice 
while not sacrificing appropriate and statutorily required detail. For 
example, if the Commission learns of three injuries on three separate 
dates in a single month, a mandatory recall notice may provide the 
month and year in which these injuries were reported, presenting 
accurate information in a shortened format. However, the Commission or 
a court retains the flexibility to order the use of exact dates or the 
use of a range of dates by month and year, depending, among other 
things, on the number of injuries and the risk involved, if it is more 
helpful to consumers.
    Comment 30--One commenter suggests that information on injuries and 
deaths is a subpart of the section on substantial product hazard and 
should be moved under that section.
    Response--A description of the substantial product hazard and a 
description of the associated injuries and deaths are separate 
categories of information presented on a recall notice. Both the 
statute and the final rule separate these categories of information. 
See, e.g., sections 15(i)(2)(D) and (G) of the CPSA. The information 
presented under substantial product hazard is a short, factual 
statement regarding the actual or potential harm, i.e., choking, 
laceration, drowning, while the number and description of injuries 
reports actual injuries that have occurred. In some instances, for 
example, the risk of injury for choking may be present, but no reported 
injuries have occurred.
    Comment 31--Many comments address Sec.  1115.27(h) regarding 
identification of manufacturers on a mandatory recall notice. A few 
comments are favorable, but many comments question the value of 
identifying a foreign manufacturer, and suggest that this information 
is confidential business information subject to trade secret 
protection.
    A few comments simply state that while the identification of 
manufacturers may be helpful to the CPSC, it is not helpful to a 
consumer and may be confusing with regard to who is responsible for the 
recall. Several commenters opine that not only is the information 
irrelevant to an effective recall and the stated goals of a recall 
notice under section 214 of the CPSIA, but the identity of foreign 
manufacturers is proprietary, confidential business information which 
should only be required to be provided to the Commission under trade 
secret protection. These commenters state that the CPSIA does not 
require identification of a foreign manufacturer, and that the name of 
the importer and country of origin should be sufficient. Moreover, 
publishing the name of foreign manufacturers can cause significant harm 
to a firm and is information not shared with competitors. Naming a 
foreign manufacturer may cause confusion to consumers, and unfairly 
place blame on foreign manufacturers when the problem, for example, may 
actually be with the design of the product. Finally, one commenter 
opines that information on the country of origin is not helpful to the 
consumer and detracts from the overall effectiveness of a recall 
notice. Such information may confuse consumers to believe that all 
products manufactured in a country are dangerous.
    Response--Section 15(i)(2)(E) of the CPSA requires that a mandatory 
recall notice shall include ``[a]n identification of the manufacturers 
* * * of the product.'' Section 3(a)(11) of the CPSA defines 
``manufacturer'' as ``any person who manufactures or imports a consumer 
product.'' The term ``manufactured'' means to ``manufacture, produce, 
or assemble.'' Section 3(a)(10) of the CPSA. A consumer product 
includes ``any article, or component part thereof, produced or 
distributed'' for sale to consumers. Section 3(a)(5) of the CPSA. Thus, 
any firm that manufactures, produces, assembles or imports a consumer 
product, or any component part thereof, may be characterized as a 
product manufacturer. As is often the case, a consumer product may have 
more than one manufacturer. This fact is acknowledged both by the 
statute, which employs the plural term ``manufacturers'' and the rule, 
which provides that ``[a] recall notice must identify each manufacturer 
(including importer) of the product and the country of manufacture.''
    The identity of a foreign manufacturer is not a trade secret or 
commercially sensitive information in every case. For example, many 
voluntary recall notices issued in the past identify a foreign 
manufacturer. In the context of a mandatory recall situation, whether 
identification of a foreign manufacturer is indeed trade secret, 
confidential information, and/or whether an exception to section 6 of 
the CPSA applies, will necessarily be litigated in the judicial or 
administrative proceeding. These issues require a fact-dependent, 
individualized analysis in every case; it is not something that could 
ever be decided broadly and apply to all manufacturers. To the extent 
that section 6 of the CPSA is applicable, the Commission acknowledges 
that it, and a firm, must comply with the law and any exceptions 
thereto.
    Comment 32--Another commenter opines that the rule is ambiguous as 
to whether different information is required from foreign and domestic 
manufacturers. The commenter would clarify the rule to state that a 
recall notice must identify a domestic manufacturer's legal name, city, 
and state of headquarters, or if a foreign manufacturer is involved, 
identify the city and country of its headquarters (but omit the name of 
the company). Another commenter agrees that the manufacturer name and 
country of manufacture should be on the recall notice, but not the city 
and state of the headquarters. This commenter does not see any added 
benefit to the consumer to have this information.
    Response--The rule anticipates that many consumer products have 
both foreign and domestic manufacturers and importers, both of whom 
must be identified. The rule requires all manufacturers to be 
identified by their legal names. Additionally, domestic companies 
should be identified by the city and state of their headquarters, and 
foreign companies should be identified by the city and country of their 
headquarters. The Commission agrees that the language in the proposed 
rule was unclear with regard to what identifying information is 
required for foreign manufacturers. The final rule clarifies that 
foreign manufacturers must be identified by: (i) Legal name; (ii) city; 
and (iii) country of headquarters.

[[Page 3366]]

    Comment 33--One commenter suggests that the Commission require a 
manufacturer's Web site address to be listed with the identification 
information, in addition to name, trade name, city, and state, to 
facilitate recall information dissemination and allow consumers to 
access recall and remedy information via the company's Web site.
    Response--The Commission declines to require that a manufacturer's 
Web address be listed as identifying information in every mandatory 
recall notice. A Web address for recall information is already provided 
elsewhere on the recall notice. The manufacturer may or may not have a 
Web site and may or may not be the firm in charge of a recall. The 
Commission does not want consumers to be confused with regard to which 
entity is responsible for the recall, or to deluge the wrong firm with 
phone calls about a recall.
    Comment 34--One commenter suggests excluding small importers that 
are not the sole importer or retailer from any provision that allows 
them to be characterized as a ``manufacturer'' or ``significant 
retailer'' for purposes of a recall, because the burden on small 
importers would be too great and they would not likely have the type of 
information available to manufacturers and retailers to implement a 
recall. However, another commenter observed that the burden on small 
businesses should not be great because there are few mandatory recalls.
    Response--Determining which firm is responsible for conducting a 
recall is outside the scope of the final rule, which focuses on 
guidelines and requirements for information categories to include in a 
mandatory recall notice.
    Comment 35--Many commenters request clarification of proposed Sec.  
1115.27(i) with regard to identification of ``significant retailers,'' 
arguing that the rule is too vague regarding what criteria will be used 
to determine a ``significant retailer.''
    One commenter opines that singling out retailers does not help to 
identify a product. This information is only relevant if the remedy is 
to return the product to the retailer, or if there is only one 
retailer. Moreover, several commenters prefer to keep the current 
system whereby no specific retailer is named, and the firm can rely on 
language such as ``sold at department store and retail stores 
nationwide.''
    Response--Section 15(i)(2)(E) of the CPSA requires that a mandatory 
recall notice include ``[a]n identification of the * * * significant 
retailers of the product.'' Thus, the statute requires the 
identification of ``significant'' retailers but does not define 
``significant.''
    Comment 36--Several commenters believe the language regarding 
``significant retailers'' should be expanded to include all retailers, 
instead of just ``significant'' retailers. Many commenters state that 
if only a few retailers are listed, consumers may be confused and 
believe that their product is not at issue in the recall simply because 
the retailer they purchased the product from is not listed. Moreover, 
this scenario would leave out the majority of retailers where the 
products were actually purchased and may compromise dissemination of 
recall information to the majority of the consuming public. One 
commenter suggests that, in order to keep the notice short, the 
Commission should require the notice to state that the retailer list is 
not exhaustive and to provide a Web site address where the consumer can 
find an exhaustive list of retailers. Several commenters claim that, 
because the definition of ``significant retailer'' is so vague, firms 
will simply list all retailers to avoid non-compliance. These 
commenters argue that a long list of retailers will increase the length 
of the notice and make it difficult for consumers to obtain the 
information required for an effective recall.
    Response--Section 15(i)(2)(E) of the CPSA requires that a mandatory 
recall notice identify significant retailers of the product. Although 
the statute does not define ``significant,'' the Commission does not 
read it to mean identification of all retailers. While the Commission 
could identify all retailers on its Web site if it were in the interest 
of public safety, it declines to do so in every mandatory recall 
scenario. First, the statute requires identification of ``significant'' 
retailers, not all retailers. Second, it is unclear whether requiring 
every mandatory recall notice to include an exhaustive list of 
retailers on the CPSC Web site would increase recall effectiveness or 
would be an efficient use of Commission resources. Such a requirement 
may become burdensome with no added value to consumers. Finally, 
listing significant retailers will not result in a lengthy recall 
notice because the Commission retains the discretion to control the 
substance, format, and organization of recall notices in the interest 
of consumer safety and recall effectiveness.
    Comment 37--Many commenters suggest that the concept of, and the 
criteria for, ``significant retailer'' be clarified and that Sec.  
1115.27(i)(5) should not contain a vague catch-all that allows the 
Commission to find a retailer significant if it ``is in the public 
interest.'' Many commenters request that the Commission set forth 
criteria the Commission will consider in determining what is in the 
public interest.
    Response--The Commission's experience with recall notices and 
identification of retailers is that such information helps consumers to 
determine whether or not they may have the defective product. 
Accordingly, the rule provides four circumstances under which 
identifying a retailer may be helpful to consumers to identify a 
product: (i) An exclusive retailer; (ii) a retailer that is also an 
importer of the product; (iii) a retailer with national and/or 
regionally located stores; and (iv) a retailer that holds or sold a 
significant number of the defective products. The rule also provides 
the Commission, or a court, with the flexibility to determine that 
although a retailer may not fall into one of the four enumerated 
categories, circumstances may arise whereby designation of the retailer 
as ``significant'' for a particular mandatory recall would help 
consumers identify the product. The final rule maintains this 
flexibility because: (i) It is not possible to anticipate every 
circumstance where listing a particular retailer may become helpful to 
consumers beforehand; and (ii) the Commission, under sections 15(c) and 
(d) of the CPSA, and a court, pursuant to section 12 of the CPSA, 
already have final authority over the form and content of mandatory 
recall notices. Such authority is not altered by section 15(i) of the 
CPSA and the Commission declines to do so in the final rule.
    Comment 38--Some commenters state that the Commission failed to 
define ``regional retailer,'' or ``regionally-located.'' Accordingly, 
these commenters argue that the rule is too vague.
    Response--The term ``regional'' should be understood based on its 
ordinary and customary usage. For example, a regional chain could be 
located in one region of the state of California, it could comprise 
affiliated stores existing in an entire state, or it could comprise 
affiliated stores located in a group of states, or finally, stores 
located in one or more regions of the United States.
    Comment 39--Some commenters note that there are many situations 
where regional chains or ``mom and pop'' stores sell the majority of 
the products and collectively outsell a national retailer, but the 
national retailer may end up being named as a ``significant retailer'' 
because, compared to any one store, it may have sold more products. 
Several commenters observe that the rule, as

[[Page 3367]]

proposed, will likely result in a small number of national retailers 
being named in virtually every recall notice, which will dilute the 
purpose of the information. One commenter suggests addressing this 
problem by changing Sec.  1115.27(i)(4) from ``a significant number of 
the total manufactured'' to ``a majority of the total manufactured.'' 
This commenter believes that naming one retailer where a majority of 
the products were sold would be more helpful to the consumer than 
listing every ``significant retailer.''
    Response--With regard to the idea that listing some, but not all, 
retailers will cause consumer confusion, this has not been the 
Commission's experience. For example, a recall notice can list major 
retail outlets, but also explain that the list of retailers is not 
exhaustive. In a situation where Store A sold 40% of the defective 
product and more than 50 smaller home centers and hardware stores sold 
the remaining 60%, a recall notice could employ additional, helpful 
language describing the types of stores where the product was sold 
without causing the notice to become unduly long and unreadable: 
``Product was sold nationwide at Store A and at home centers and 
hardware stores nationwide.''
    The Commission declines to adopt the suggestion that the required 
statutory term ``significant'' be modified to mean a ``majority'' of 
the products. The statute itself requires identification of 
``significant'' retailers. Many situations arise where there may be two 
or three retailers that sell 60% to 80% of the products. While no 
retailer individually sold a majority of the products, listing these 
retailers is helpful to consumers to determine whether or not they may 
have the defective product.
    Comment 40--One commenter would expand the description of retailers 
to include contractors, so that contractors must notify consumers when 
the materials were used in building projects. The commenter cited, as 
an example, the drywall situation, where the nature of the product 
makes it difficult for consumers to discern whether the defective 
product is in their home.
    Response--The Commission declines to include the term 
``contractors'' in the description of retailers, but this does not 
preclude the fact that there may be situations when contractors may be 
considered to be retailers. Even if the Commission were to include 
contractors in the description of retailers, it would not address the 
commenter's primary concern that contractors notify homeowners about 
the materials used in building projects. The statute at issue here, 
section 15(i) of the CPSA, does not impose any specific obligation on a 
retailer to notify consumers. Being listed as a ``significant 
retailer'' does not create any obligation on the part of retailers so 
listed; the information is present solely to assist consumers with 
product identification.
    Comment 41--One commenter opines that the dates of manufacture and 
sale under proposed Sec.  1115.27(j) (now renumbered as Sec.  
1115.27(k) in the final rule) are too expansive. Manufacturers date 
code products by the date of manufacture, not the date of sale. 
Manufacturers often do not know the date a product first hits retail 
shelves. Providing more than manufacturing dates may be confusing to 
consumers. The current system of citing manufacturing dates by date 
code, or date of sale if known, has been successful.
    Response--Section 15(i)(2)(F) of the CPSA requires that a mandatory 
recall notice include ``[t]he dates between which the product was 
manufactured and sold.'' The statute thus requires both the dates of 
manufacture and the dates of sale. If a manufacturer does not have this 
information, it is expected that, where available, it may be provided 
by retailers or distributors.
    Comment 42--A few commenters suggest expanding the price 
requirement in proposed Sec.  1115.27(k) (now renumbered as Sec.  
1115.27(l) in the final rule). One commenter would require suggested 
retail price, prices known to the manufacturer, and the highest and 
lowest retail price known. Another commenter suggests that the 
approximate price range is not helpful enough, and that the price range 
should be made specific for geographic locations.
    One commenter opines that a price should only be required when the 
remedy is a purchase price refund. Otherwise, this information is 
unhelpful and clutters the recall notice.
    Response--The Commission typically requires approximate price 
information in all recall notices to assist with product 
identification. We decline to require every price known to the 
manufacturer in every mandatory recall notice; the approximate price 
range is sufficient for product identification purposes, and to assist 
the consumer in understanding what the price refund may be. Further, 
providing a price range for each specific geographic location in every 
recall situation is not always practical. It is unclear whether such 
information will add sufficient value to the recall notice to offset 
the use of resources in every recall situation. The Commission retains 
the flexibility, however, to require more information on price if it 
would assist consumers.
    Comment 43--One commenter states that proposed Sec.  1115.27(n) 
(now renumbered as Sec.  1115.27(o) in the final rule) regarding 
``other information'' that the Commission or a court may deem 
appropriate for inclusion in a recall notice should state what types of 
additional information may be required to put firms on notice. The 
commenter argues that without such clarification an aggrieved party may 
later argue that a requirement placed on it is burdensome and not 
contemplated by the rule. Accordingly, the commenter suggests that the 
rule clarify that Sec.  1115.27 is exhaustive as can be currently 
contemplated, but that other requirements will be included as the 
situation demands. At a minimum, the rule should state that future 
requirements will be based on a fair assessment of the situation.
    Response--Section 15(i)(2)(I) of the CPSA provides that a mandatory 
recall notice must include ``[o]ther information the Commission deems 
appropriate.'' Moreover, when a mandatory recall notice is ordered by a 
court or the Commission, it has authority over the final form and 
content of the recall notice and can require additional information 
deemed appropriate in particular cases pursuant to sections 12, 15(c) 
and 15(d) of the CPSA. Thus, the authority to include any other 
information the Commission deems appropriate in a mandatory recall 
notice does not solely originate from section 15(i) of the CPSA. The 
rule reflects the Commission or a court's inherent authority with 
regard to the form and content of mandatory recall notices, and the 
Commission declines to limit its own authority in the rule.
6. Section 1115.28--Multiple Products or Models
    Proposed Sec.  1115.28 would require the notice for each product or 
model covered by a recall notice to meet the requirements of this 
subpart.
    We received no comments on this provision and have finalized it 
without change.
7. Section 1115.29--Final Determination Regarding Form and Content
    Comment 44--Most commenters support Sec.  1115.29 which states that 
the Commission or the Court has the final determination as to the form 
and content of a recall notice. Consumer groups, in particular, support 
this rule to level the influence that firms have traditionally had over 
form and content. One commenter suggests imposing a

[[Page 3368]]

deadline on firms for disseminating the recall notice after Commission 
approval and immediate posting on the CPSC's Web site after approval. 
One commenter, however, feels that the rule is vague and allows the 
CPSC excessive discretion with regard to recall form and content. This 
commenter suggests more specificity and criteria be inserted into the 
rule to create more uniform expectations for firms. Another commenter 
suggests imposing a deadline on the Commission's approval process, and 
allowing firms to disseminate a recall notice if the Commission has not 
rejected or approved the proposed recall notice within the time frame 
in order to get recall information out to the public as soon as 
possible.
    Response--The Commission and/or a court have statutory authority to 
control the final form and content of mandatory recall notices. 
Mandatory recall notices must be approved by the Commission before they 
are disseminated. Sections 15(c)(1) and 15(d)(2) of the CPSA. Nothing 
in section 15(i) of the CPSA or the final rule changes this control; 
the statute merely requires that the Commission provide guidance on a 
uniform set of information that firms can expect to find in a mandatory 
recall notice, as well as sets forth certain requirements for mandatory 
recall notices which can be altered by the Commission in particular 
recall scenarios as necessary or appropriate. Thus, the date of 
dissemination by both the CPSC and the firm is directed by the CPSC, 
and the CPSC posts all recall press notices on its Web site at http://www.CPSC.gov after approval by the Commission.

IV. Environmental Impact

    Generally, the Commission's regulations are considered to ``have 
little or no potential for affecting the human environment,'' and 
environmental assessments and impact statements are not usually 
prepared. See 16 CFR 1021.5(c). The final rule establishes requirements 
and guidelines for mandatory recall notices is not expected to have an 
adverse impact on the environment. Thus, the Commission concludes that 
no environmental assessment or environmental impact statement is 
required in this proceeding.

V. Paperwork Reduction Act of 1995

    The rule does not impose information collection requirements. 
Rather, the rule sets forth a uniform set of information categories 
that are either statutorily required or provided as guidelines by the 
Commission for use in recall notices that are ordered by the Commission 
or a United States district court in individual enforcement actions 
under sections 12, 15(c) or 15(d) of the CPSA. Additionally, under 5 
CFR 1320.4(a)(2), the Paperwork Reduction Act requirements do not apply 
to collections of information ``during the conduct of a civil action to 
which the United States or any official or agency thereof is a party, 
or during the conduct of an administrative action * * * against 
specific individuals or entities.'' Accordingly, it is not subject to 
the Paperwork Reduction Act, 44 U.S.C. 3501 through 3520.

VI. Executive Order 12988

    According to Executive Order 12988 (February 5, 1996), agencies 
must state in clear language the preemptive effect, if any, of new 
regulations. The requirements and guidelines contained in the rule do 
not impact the States, as they only apply to mandatory recalls ordered 
by the Commission or a United States district court. Moreover, section 
26 of the CPSA with regard to preemption only addresses the preemptive 
effect of consumer product safety standards under the CPSA. The current 
rule is not a consumer product safety standard under the Act. 
Accordingly, the Commission has determined that this rule does not 
contain requirements or guidelines that impact the States.

VII. Regulatory Flexibility Act

    The Regulatory Flexibility Act (``RFA'') generally requires that 
agencies review proposed rules for their potential economic impact on 
small entities, including small businesses. Section 603 of the RFA 
calls for agencies to prepare and make available for public comment an 
initial regulatory flexibility analysis describing the impact of the 
proposed rule on small entities and identifying impact-reducing 
alternatives. 5 U.S.C. 603. Section 605(b) of the RFA, however, states 
that this requirement does not apply if the head of the agency 
certifies that the rule will not, if promulgated, have a significant 
economic impact on a substantial number of small entities, and the 
agency provides an explanation for that conclusion.
    This final rule will have little or no effect on small businesses. 
First, this rule consists of guidelines (which do not require a 
regulatory flexibility analysis) and recall notice content requirements 
that are largely dictated by the CPSIA. Second, these guidelines and 
requirements apply in the context of an administratively adjudicated 
order to a specific party to issue a recall notice. Such mandatory 
recalls have occurred infrequently in the Commission's history. 
Finally, the substantive authority for a court or the Commission to 
order that a mandatory recall notice issue comes from existing law, 
sections 12, 15(c) and 15(d) of the CPSA, rather than the final rule. 
Therefore, the Commission concludes that the final rule will not have a 
significant economic impact on a substantial number of small entities.

VIII. Effective Date

    In the preamble to the proposed rule, the Commission indicated that 
the final rule would be effective upon publication in the Federal 
Register based upon good cause shown (74 FR 11885). However, in its 
vote to approve the issuance of the final rule, the Commission voted to 
follow the APA standard, codified at 5 U.S.C. 553(d), such that the 
effective date of the final rule is 30 days after publication in the 
Federal Register.

List of Subjects in 16 CFR Part 1115

    Administrative practice and procedure, Business and industry, 
Consumer protection, Reporting and recordkeeping requirements.

0
For the reasons stated above, the Commission amends chapter II of title 
16 of the Code of Federal Regulations as follows:

PART 1115--SUBSTANTIAL PRODUCT HAZARD REPORTS

0
1. The authority citation for part 1115 continues to read as follows:

    Authority: 15 U.S.C. 2061, 2064, 2065, 2066(a), 2068, 2069, 
2070, 2071, 2073, 2076, 2079, and 2080.


0
2. Add a new Subpart C to read as follows:
Subpart C--Guidelines and Requirements for Mandatory Recall Notices
Sec.
1115.23 Purpose.
1115.24 Applicability.
1115.25 Definitions.
1115.26 Guidelines and policies.
1115.27 Recall notice content requirements.
1115.28 Multiple products or models.
1115.29 Final determination regarding form and content.

Subpart C--Guidelines and Requirements for Mandatory Recall Notices


Sec.  1115.23  Purpose.

    (a) The Commission establishes these guidelines and requirements 
for recall notices as required by section 15(i) of the Consumer Product 
Safety Act, as amended (CPSA) (15 U.S.C. 2064(i)). The guidelines and 
requirements set

[[Page 3369]]

forth the information to be included in a notice required by an order 
under sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 
2064(c), or 2064(d)). Unless otherwise ordered by the Commission under 
section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or by a 
United States district court under section 12 of the CPSA (15 U.S.C. 
2061), the content information required in this subpart must be 
included in every such notice.
    (b) The Commission establishes these guidelines and requirements to 
ensure that every recall notice effectively helps consumers and other 
persons to:
    (1) Identify the specific product to which the recall notice 
pertains;
    (2) Understand the product's actual or potential hazards to which 
the recall notice pertains, and information relating to such hazards; 
and
    (3) Understand all remedies available to consumers concerning the 
product to which the recall notice pertains.


Sec.  1115.24  Applicability.

    This subpart applies to manufacturers (including importers), 
retailers, and distributors of consumer products as those terms are 
defined herein and in the CPSA.


Sec.  1115.25  Definitions.

    In addition to the definitions given in section 3 of the CPSA (15 
U.S.C. 2052), the following definitions apply:
    (a) Recall means any one or more of the actions required by an 
order under sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 
2064(c), or 2064(d)).
    (b) Recall notice means a notification required by an order under 
sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 2064(c), or 
2064(d)).
    (c) Direct recall notice means a notification required by an order 
under sections 12, 15(c), or 15(d) of the CPSA (15 U.S.C. 2061, 
2064(c), or 2064(d)), that is sent directly to specifically-identified 
consumers.
    (d) Firm means a manufacturer (including an importer), retailer, or 
distributor as those terms are defined in the CPSA.
    (e) Other persons means, but is not limited to, consumer safety 
advocacy organizations, public interest groups, trade associations, 
industry advocacy organizations, other State, local, and Federal 
government agencies, and the media.


Sec.  1115.26  Guidelines and policies.

    (a) General. (1) A recall notice should provide sufficient 
information and motivation for consumers and other persons to identify 
the product and its actual or potential hazards, and to respond and 
take the stated action. A recall notice should clearly and concisely 
state the potential for injury or death.
    (2) A recall notice should be written in language designed for, and 
readily understood by, the targeted consumers or other persons. The 
language should be simple and should avoid or minimize the use of 
highly technical or legal terminology.
    (3) A recall notice should be targeted and tailored to the specific 
product and circumstances. In determining the form and content of a 
recall notice, the manner in which the product was advertised and 
marketed should be considered.
    (4) A direct recall notice is the most effective form of a recall 
notice.
    (5) At least two of the recall notice forms listed in subsection 
(b) should be used.
    (b) Form of recall notice--(1) Possible forms. A recall notice may 
be written, electronic, audio, visual, or in any other form ordered by 
the Commission in an order under section 15(c) or (d) of the CPSA (15 
U.S.C. 2064(c) or (d)), or by a United States district court under 
section 12 of the CPSA (15 U.S.C. 2061). The forms of, and means for 
communicating, recall notices include, but are not limited to:
    (i) Letter, Web site posting, electronic mail, RSS feed, or text 
message;
    (ii) Computer, radio, television, or other electronic transmission 
or medium;
    (iii) Video news release, press release, recall alert, Web stream, 
or other form of news release;
    (iv) Newspaper, magazine, catalog, or other publication; and
    (v) Advertisement, newsletter, and service bulletin.
    (2) Direct recall notice. A direct recall notice should be used for 
each consumer for whom a firm has direct contact information, or when 
such information is obtainable, regardless of whether the information 
was collected for product registration, sales records, catalog orders, 
billing records, marketing purposes, warranty information, loyal 
purchaser clubs, or other such purposes. Direct contact information 
includes, but is not limited to, name and address, telephone number, 
and electronic mail address. Forms of direct recall notice include, but 
are not limited to, United States mail, electronic mail, and telephone 
calls. A direct recall notice should prominently show its importance 
over other consumer notices or mail by including ``Safety Recall'' or 
other appropriate terms in an electronic mail subject line, and, in 
large bold red typeface, on the front of an envelope and in the body of 
a recall notice.
    (3) Web site recall notice. A Web site recall notice should be on a 
Web site's first entry point such as a home page, should be clear and 
prominent, and should be interactive by permitting consumers and other 
persons to obtain recall information and request a remedy directly on 
the Web site.
    (c) Languages. Where the Commission for purposes of an order under 
section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or a 
United States district court for purposes of an order under section 12 
of the CPSA (15 U.S.C. 2061), determines that it is necessary or 
appropriate to adequately inform and protect the public, a recall 
notice may be required to be in languages in addition to English. For 
example, it may be necessary or appropriate to require a recall notice 
be in a language in addition to English when a product label is in a 
language in addition to English, when a product is marketed in a 
language in addition to English, or when a product is marketed or 
available in a geographic location where English is not the predominant 
language.


Sec.  1115.27  Recall notice content requirements.

    Except as provided in Sec.  1115.29, every recall notice must 
include the information set forth below:
    (a) Terms. A recall notice must include the word ``recall'' in the 
heading and text.
    (b) Date. A recall notice must include its date of release, 
issuance, posting, or publication.
    (c) Description of product. A recall notice must include a clear 
and concise statement of the information that will enable consumers and 
other persons to readily and accurately identify the specific product 
and distinguish it from similar products. The information must enable 
consumers to readily determine whether or not they have, or may be 
exposed to, the product. To the extent applicable to a product, 
descriptive information that must appear on a recall notice includes, 
but is not limited to:
    (1) The product's names, including informal and abbreviated names, 
by which consumers and other persons should know or recognize the 
product;
    (2) The product's intended or targeted use population (e.g., 
infants, children, or adults);
    (3) The product's colors and sizes;
    (4) The product's model numbers, serial numbers, date codes, stock 
keeping unit (SKU) numbers, and tracking labels, including their exact 
locations on the product;

[[Page 3370]]

    (5) Identification and exact locations of product tags, labels, and 
other identifying parts, and a statement of the specific identifying 
information found on each part; and
    (6) Product photographs. A firm must provide photographs. Each 
photograph must be electronic or digital, in color, of high resolution 
and quality, and in a format readily transferable with high quality to 
a Web site or other appropriate medium. As needed for effective 
notification, multiple photographs and photograph angles may be 
required.
    (d) Description of action being taken. A recall notice must contain 
a clear and concise statement of the actions that a firm is taking 
concerning the product. These actions may include, but are not limited 
to, one or more of the following: Stop sale and distribution in 
commerce; recall to the distributor, retailer, or consumer level; 
repair; request return and provide a replacement; and request return 
and provide a refund.
    (e) Statement of number of product units. A recall notice must 
state the approximate number of product units covered by the recall, 
including all product units manufactured, imported, and/or distributed 
in commerce.
    (f) Description of substantial product hazard. A recall notice must 
contain a clear and concise description of the product's actual or 
potential hazards that result from the product condition or 
circumstances giving rise to the recall. The description must enable 
consumers and other persons to readily identify the reasons that a firm 
is conducting a recall. The description must also enable consumers and 
other persons to readily identify and understand the risks and 
potential injuries or deaths associated with the product conditions and 
circumstances giving rise to the recall. The description must include:
    (1) The product defect, fault, failure, flaw, and/or problem giving 
rise to the recall; and
    (2) The type of hazard or risk, including, by way of example only, 
burn, fall, choking, laceration, entrapment, and/or death.
    (g) Identification of recalling firm. A recall notice must identify 
the firm conducting the recall by stating the firm's legal name and 
commonly known trade name, and the city and state of its headquarters. 
The notice must state whether the recalling firm is a manufacturer 
(including importer), retailer, or distributor.
    (h) Identification of manufacturers. A recall notice must identify 
each manufacturer (including importer) of the product and the country 
of manufacture. Under the definition in section 3(a)(11) of the CPSA 
(15 U.S.C. 2052(a)(11)), a manufacturer means ``any person who 
manufactures or imports a consumer product.'' If a product has been 
manufactured outside of the United States, a recall notice must 
identify the foreign manufacturer and the United States importer. A 
recall notice must identify the manufacturer by stating the 
manufacturer's legal name and the city and state of its headquarters, 
or, if a foreign manufacturer, the foreign manufacturer's legal name 
and the city and country of its headquarters.
    (i) Identification of significant retailers. A recall notice must 
identify each significant retailer of the product. A recall notice must 
identify such a retailer by stating the retailer's commonly known trade 
name. Under the definition in section 3(a)(13) of the CPSA (15 U.S.C. 
2052(a)(13)), a retailer means ``a person to whom a consumer product is 
delivered or sold for purposes of sale or distribution by such person 
to a consumer.'' A product's retailer is ``significant'' if, upon the 
Commission's information and belief, and in the sole discretion of the 
Commission for purposes of an order under section 15(c) or (d) of the 
CPSA (15 U.S.C. 2064(c) or (d)), or in the sole discretion of a United 
States district court for purposes of an order under section 12 of the 
CPSA (15 U.S.C. 2061), any one or more of the circumstances set forth 
below is present (the Commission may require manufacturers (including 
importers), retailers, and distributors to provide information relating 
to these circumstances):
    (1) The retailer was the exclusive retailer of the product;
    (2) The retailer was an importer of the product;
    (3) The retailer has stores nationwide or regionally-located;
    (4) The retailer sold, or held for purposes of sale or distribution 
in commerce, a significant number of the total manufactured, imported, 
or distributed units of the product; or
    (5) Identification of the retailer is in the public interest.
    (j) Region. Where necessary or appropriate to assist consumers in 
determining whether they have the product at issue, a description of 
the region where the product was sold, or held for purposes of sale or 
distribution in commerce, must be provided.
    (k) Dates of manufacture and sale. A recall notice must state the 
month and year in which the manufacture of the product began and ended, 
and the month and year in which the retail sales of the product began 
and ended. These dates must be included for each make and model of the 
product.
    (l) Price. A recall notice must state the approximate retail price 
or price range of the product.
    (m) Description of incidents, injuries, and deaths. A recall notice 
must contain a clear and concise summary description of all incidents 
(including, but not limited to, property damage), injuries, and deaths 
associated with the product conditions or circumstances giving rise to 
the recall, as well as a statement of the number of such incidents, 
injuries, and deaths. The description must enable consumers and other 
persons to readily understand the nature and extent of the incidents 
and injuries. A recall notice must state the ages of all persons 
injured and killed. A recall notice must state the dates or range of 
dates on which the Commission received information about injuries and 
deaths.
    (n) Description of remedy. A recall notice must contain a clear and 
concise statement, readily understandable by consumers and other 
persons, of:
    (1) Each remedy available to a consumer for the product conditions 
or circumstances giving rise to the recall. Remedies include, but are 
not limited to, refunds, product repairs, product replacements, 
rebates, coupons, gifts, premiums, and other incentives.
    (2) All specific actions that a consumer must take to obtain each 
remedy, including, but not limited to, instructions on how to 
participate in the recall. These actions may include, but are not 
limited to, contacting a firm, removing the product from use, 
discarding the product, returning part or all of the product, or 
removing or disabling part of the product.
    (3) All specific information that a consumer needs in order to 
obtain each remedy and to obtain all information about each remedy. 
This information may include, but is not limited to, the following: 
Manufacturer, retailer, and distributor contact information (such as 
name, address, telephone and facsimile numbers, e-mail address, and Web 
site address); whether telephone calls will be toll-free or collect; 
and telephone number days and hours of operation including time zone.
    (o) Other information. A recall notice must contain such other 
information as the Commission for purposes of an order under section 
15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), or a United States 
district court for purposes of an order under section 12 of the CPSA 
(15 U.S.C. 2061), deems appropriate and orders.

[[Page 3371]]

Sec.  1115.28  Multiple products or models.

    For each product or model covered by a recall notice, the notice 
must meet the requirements of this subpart.


Sec.  1115.29  Final determination regarding form and content.

    (a) Commission or court discretion. The recall notice content 
required by this subpart must be included in a recall notice whether or 
not the firm admits the existence of a defect or of an actual or 
potential hazard, and whether or not the firm concedes the accuracy or 
applicability of all of the information contained in the recall notice. 
The Commission will make the final determination as to the form and 
content of the recall notice for purposes of an order under section 
15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), and a United 
States district court will make the final determination as to the form 
and content of a recall notice for purposes of an order under section 
12 of the CPSA (15 U.S.C. 2061).
    (b) Recall notice exceptions. The Commission for purposes of an 
order under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or 
(d)), or a United States district court for purposes of an order under 
section 12 of the CPSA (15 U.S.C. 2061), may determine that one or more 
of the recall notice requirements set forth in this subpart is not 
required, and will not be included, in a recall notice.
    (c) Commission approval. Before a firm may publish, broadcast, or 
otherwise disseminate a recall notice to be issued pursuant to an order 
under section 15(c) or (d) of the CPSA (15 U.S.C. 2064(c) or (d)), the 
Commission must review and agree in writing to all aspects of the 
notice.

    Dated: January 13, 2010.
Todd A. Stevenson,
Secretary, United States Consumer Product Safety Commission.
[FR Doc. 2010-873 Filed 1-20-10; 8:45 am]
BILLING CODE 6355-01-P