[Federal Register: July 24, 1997 (Volume 62, Number 142)]
[Notices]
[Page 39827-39828]
From the Federal Register Online via GPO Access
[wais.access.gpo.gov]
[DOCID:fr24jy97-53]
[[Page 39827]]
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CONSUMER PRODUCT SAFETY COMMISSION
Conditions Under Which the Staff Will Refrain From Making
Preliminary Hazard Determinations
AGENCY: Consumer Product Safety Commission.
ACTION: Notice.
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SUMMARY: The Consumer Product Safety Act requires manufacturers,
distributors, and retailers of consumer products distributed in
commerce to notify the Commission of certain defects,
unreasonable risks, or non-compliance with voluntary or mandatory
standards. The Commission has made permanent its ``No PD''
program: The staff refrains from making a preliminary hazard
determination when firms report and, within 20 working days,
implement an acceptable corrective action.
DATES: The Commission's revised procedures became permanent on
March 27, 1997.
FOR FURTHER INFORMATION CONTACT:
Marc J. Schoem, Office of Compliance, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814 (mailing
address: Washington, DC 20207); telephone 301-504-0608, extension
1365; e-mail address ``sect15@cpsc.gov.''
SUPPLEMENTARY INFORMATION:
A. Background
Under section 15(b) of the Consumer Product Safety Act
(CPSA), 15 U.S.C. 2064(b), manufacturers, distributors, and
retailers of consumer products must report certain potential
product hazards to the Commission. They must report immediately
if they obtain information which reasonably supports the
conclusion that a product (1) fails to comply with certain
mandatory or voluntary standards, (2) contains a defect which
could create a substantial product hazard, or (3) creates
an unreasonable risk of serious injury or death. 15 U.S.C.
2064(b).
If the Commission believes that a product presents a
substantial product hazard under the CPSA, 15 U.S.C. Sec. 2064
(c) and (d), or contains a defect which creates a substantial
risk of injury to children under the Federal Hazardous Substances
Act, 15 U.S.C. Sec. 1274(a), (b) and (c), it may pursue
corrective action.
After receiving a report, the Commission staff evaluates the
hazard. If the available facts justify pursuing corrective action
for the product, the staff generally makes a preliminary
determination (``PD'') of ``substantial product hazard'' or
``substantial risk of injury to children.'' See 16 CFR
1115.12(a).
B. Initiation of ``No PD'' Pilot Program
On August 17, 1995, the Commission initiated a six-month
pilot program in which, under certain conditions, the Office of
Compliance staff would not make a preliminary determination. See
60 Fed. Reg. 42848 (Aug. 17, 1995). Later, the Commission
extended the pilot program through March 1997.
The Commission initiated the pilot program to use staff
resources more efficiently and to promote quicker recalls. In
addition, the Commission hoped to reduce any disincentive to
companies that want to report and undertake corrective action,
but fear the consequences of a staff preliminary determination.
When the staff preliminarily determines that a product
presents a substantial product hazard or creates a substantial
risk of injury to children, it requests that the reporting
company take corrective action. If a company acts promptly to
correct a defective product, staff resources can be devoted to
helping the company recall the product instead of investigating
the defect and making the preliminary determination.
The Commission designed the pilot program to ``reward''
companies that acted quickly on a corrective action. The staff
made no preliminary determination concerning the products of
those companies.
C. Results of Pilot Program
The pilot program was successful. During its first six
months, companies participating in the program initiated 57
corrective action plans that affected approximately 3.5 million
products. By the end of the pilot program's extension, companies
had initiated 140 recalls of approximately 12.9 million products.
On average, companies in the pilot program took 14 working
days to initiate corrective action plans. The staff sometimes
granted an extension of time for issuance of a joint news release
or final staff approval of an alternative notice program. In most
of those cases, however, the firm's corrective action plan was
underway within 20 working days.
During the pilot program, companies undertook corrective
actions for a variety of products. They included children's
articles with small parts that presented choking hazards,
products that collapsed and presented impact hazards, bicycles
and recreational vehicles that could cause falls or loss of
control, products that presented the risk of carbon monoxide
poisoning, electrical products that presented shock and
fire risks, and power tools that could cause serious lacerations.
Industry response to the pilot program was positive. During
the program, more than one-third of the companies making section
15 reports initiated corrective actions under the ``no
preliminary determination'' approach.
D. Permanent Program
After reviewing the results of the pilot program, the
Commission revised its procedures on a permanent basis effective
March 24, 1997. The permanent program is governed by the
following requirements and procedures:
1. If a company reports and implements within 20 working days
after filing an initial report a corrective action that the staff
believes will be effective, the staff will generally refrain from
making a preliminary determination. ``Implement'' means issuance
of a news release or other form of public notice approved by the
staff commencing a consumer-level corrective action.
If the Commission believes that more than 20 working days is
necessary, the Director of the Division of Corrective Actions may
extend the time period for any appropriate reason, including
that: (a) technically complex issues must be resolved to assure
the staff that the company's action is adequate (for example,
laboratory testing is necessary); (b) retailers and distributors
must be notified in advance so that the plan will be effective;
or (c) the news release must be scheduled for optimum coverage
(for example, a video news release is necessary).
2. A company's reporting obligations remain unchanged.
Specifically, companies that have an obligation to notify the
Commission under section 15(b) or section 37 of the CPSA, or
section 102 of the Child Safety Protection Act, must continue to
do so even when they believe the risk does not warrant corrective
action.
3. A company must file a full report under 16 CFR 1115.13(d).
In particular, the report must include copies of complaints and
claims, which is crucial for staff evaluation and which many
companies currently omit.
4. A company must advise the staff that it wishes to
participate in the program.
5. A company must submit a proposed corrective action plan in
sufficient time for the staff to review and analyze it. In
addition, the staff must have sufficient time to work out the
details of the corrective action with the company. All of this
must occur before the company initiates the plan
[[Page 39828]]
within 20 working days of filing its report.
6. A company's proposed corrective action plan must include:
(a) A description of the recall action (refund, repair, or
replacement) that the company will take to eliminate the
identified risk.
(b) Sufficient product design, incident, and testing
information to allow the staff to determine whether the proposed
action corrects the identified problem and the problem is limited
to the model(s) and production dates identified by the company.
Such information should include, but is not limited to: consumer
complaints, test data, engineering drawings, material
specifications, samples of product, and/or component parts, as
needed. If the needed information and documentation is being
compiled, but is not yet available, the company must provide the
date it expects to forward the information to CPSC.
CPSC staff must have sufficient time to review the information
and respond within the 20 working day time limit.
(c) Usually, the company's proposed plan must include notice
of the recall to distributors, retailers, and consumers of the
subject product. The notice must describe the product, the
hazard, the number and type of injuries that have been reported,
the type of injury that can occur, and the action to be taken in
plain language understandable to the people to whom the notice is
directed. Generally, the plan must include a joint news release
with the Commission announcing the recall, letters and
instructions to retailers and distributors, point-of-purchase
posters, and, depending upon the level of risk, the population
at risk, age and number of products involved, additional notice.
Supplementary notice may include a video news release, print
and/or radio advertisements, incentives or bounties to encourage
consumer response, posters for specific audiences, such as for
posting in pediatricians' offices, medical clinics, national
parks and campgrounds, and repair shops (see Corrective Action
Handbook, available for CPSC Division of Corrective Actions). In
those cases where all purchasers can be contacted directly, a
news release may not be necessary.
(d) An agreement that the Commission may publicize the terms
of the plan and inform the public of the nature and the extent of
the alleged hazard. The consumer notice should be targeted to
reach a significant portion of the public likely to have
purchased the subject product.
(See 16 CFR Sec. 1115.20(a) and CPSC Corrective Action Handbook.)
7. The corrective action plan and notice must be acceptable
to the staff. The staff will consider whether the corrective
action plan adequately addresses the risk of injury presented by
the product and whether the notice and corrective action plan are
designed to make the plan as effective as is reasonably possible
given the nature of the product and the risk.
8. The staff will provide expedited review of every proposal
submitted and work with every interested company to develop an
acceptable corrective action plan that can be implemented within
20 working days. However, there may be cases where the staff
cannot evaluate and approve implementation of a corrective action
plan within 20 working days, even though the company has
submitted all the necessary information in a timely manner.
Similarly, there may be cases where the staff and firm agree that
notice and corrective action should occur after 20 working days
have passed (for example, in the case of a seasonal product). So
long as delay is not caused by or the fault of the company, the
staff generally will not make a preliminary hazard determination.
9. If corrective action is implemented within 20 working
days, staff will acknowledge in writing that the company has
submitted information under section 15(b) of the CPSA and that,
based on available information, the proposed corrective action
plan is adequate. In addition, the staff will advise the company
that it has a continuing obligation to report new or different
information that may affect the scope, prevalence or seriousness
of the defect or hazard. Once the company implements its
corrective action plan, the staff will monitor its progress.
10. If the company does not implement a corrective action
acceptable to the staff within 20 working days, the staff will
continue its evaluation and will preliminarily determine whether
the product contains a defect that creates a substantial risk of
injury to children under the FHSA or presents a substantial
product hazard under the CPSA. The staff will so inform the
company.
11. A company should not delay its report under section 15(b)
of the CPSA in order to prepare a corrective action plan. The
staff will not refrain from making a preliminary determination if
the information available suggests that a company did so.
Dated: July 21, 1997.
Todd A. Stevenson,
Deputy Secretary, Consumer Product Safety Commission.
[FR Doc. 97-19554 Filed 7-23-97; 8:45 am]
BILLING CODE 6355-01-M