[Federal Register Volume 67, Number 79 (Wednesday, April 24, 2002)]
[Proposed Rules]
[Pages 20062-20070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9960]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Metal-Cored Candle Wicks Containing Lead and Candles With Such
Wicks; Notice of Proposed Rulemaking
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed Rule.
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SUMMARY: The Commission is proposing to declare that metal-cored candle
wicks containing more than 0.06 percent lead by weight in the metal and
candles with such wicks are hazardous substances and to ban such wicks
and candles with such wicks.\1\ The Commission is issuing these
proposed rules under authority of the Federal Hazardous Substances Act.
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\1\ The Commissioners voted 2-0 to issue this notice of proposed
rulemaking.
DATES: Written comments in response to this notice must be received by
the Commission no later than July 8, 2002.
Comments on elements of the proposed rules that, if issued, would
constitute collection of information requirements under the Paperwork
Reduction Act may be filed with the Office of Management and Budget
(``OMB'') and with the Commission. Comments will be received by OMB
until June 24, 2002.
[[Page 20063]]
ADDRESSES: Comments should be mailed, preferably in five (5) copies, to
the Office of the Secretary, Consumer Product Safety Commission,
Washington, DC 20207, or delivered to the Office of the Secretary,
Consumer Product Safety Commission, Room 502, 4330 East-West Highway,
Bethesda, Maryland 20814; telephone (301) 504-6800. Comments also may
be filed by facsimile to (301) 504-0127 or by e-mail to [email protected]. Comments should be captioned ``NPR for Candle Wicks
Containing Lead.''
Comments to OMB should be directed to the Desk Officer for the
Consumer Product Safety Commission, Office of Information and
Regulatory Affairs, OMB, Washington, DC 20503. The Commission asks
commenters to provide copies of such comments to the Commission's
Office of the Secretary, with a caption or cover letter identifying the
materials as comments submitted to OMB on the proposed collection of
information requirements for the proposed ban on certain candle wicks
and candles made with such wicks.
FOR FURTHER INFORMATION CONTACT: Kristina Hatlelid, Ph.D., M.P.H.,
Project Manager, Directorate for Health Sciences, Consumer Product
Safety Commission, Washington, DC 20207; telephone (301) 504-0994, ext.
1389.
SUPPLEMENTARY INFORMATION:
A. Background
On February 24, 2000, the U.S. Consumer Product Safety Commission
(CPSC or Commission) received a petition from Public Citizen requesting
that the Commission ban candles with lead-containing wicks and wicks
sold for candle-making that contain lead. On February 29, 2000, CPSC
received a similar petition from the National Apartment Association and
the National Multi Housing Council. These petitions were docketed
collectively under the Federal Hazardous Substances Act (FHSA)
(Petition No. HP 00-3) on March 17, 2000.
After analysis of the available data on lead-cored candle wicks and
the information provided by the petitioners, the CPSC staff transmitted
a briefing package to the Commission recommending that the Commission
proceed with rulemaking to ban lead-cored candle wicks. The staff
recommended that a lead-cored wick be defined as a wick containing a
metal core with greater than 0.06 percent lead by weight in the metal,
since laboratory test data indicate that burning candles with metal-
cored wicks with lead concentrations of 0.06 percent or less by weight
does not result in detectable emissions of lead into the air. On
February 20, 2001, the Commission issued an advance notice of proposed
rulemaking (ANPR) that could lead to a ban on metal-cored wicks
containing more than 0.06 percent lead by weight in the metal and
candles with such wicks. 66 FR 10863.
B. The Product
Lead-cored wicks are candle wicks with a metal wire in the center
made of lead or lead alloy. The metal core is used to provide
structural rigidity to the wick, i.e., to keep the wick straight during
candle production, and to provide an upright wick during burning.
C. The Risk of Illness
As a lead-cored wick candle burns, some of the lead may vaporize
and be released into the air. This airborne lead may be inhaled. Some
of this lead may deposit onto floors, furniture, and other surfaces in
the room where children may be exposed to it. One cannot tell by
looking at the wick core if it is made of lead, and there is no simple
way for a consumer to determine its lead content. The presence of lead
in a wick can be determined only by laboratory analysis.
Similarly, one cannot tell if lead is being released from a burning
candle by observing smoke or soot; nor can one tell that lead is not
being released by the lack of visible emissions. Determination of lead
in room air or on surfaces must be done by professionals.
The toxic effects of lead and the risk to consumers, especially
children, from exposure to lead emitted from lead-cored wick candles,
including neurological damage, delayed mental and physical development,
attention and learning deficiencies, and hearing problems, were
detailed in the Commission briefing package on Petition No. HP 00-3.\2\
In that briefing package, CPSC staff concluded that, under reasonable
assumptions, exposure of children to indoor air lead levels from
candles emitting 430 micrograms of lead per hour or more could result
in elevated blood levels (greater than 10 micrograms of lead per
deciliter of blood). Laboratory investigations by CPSC staff and others
indicate that lead-cored wick candles can emit more than 3,000
g of lead per hour during candle burning.\3\ Thus, the
Commission believes that under certain expected use conditions, the
lead emitted from burning candles with lead-cored wicks presents a risk
to consumers of substantial illness from exposure through inhalation of
airborne lead. Children may also be exposed to lead that deposits onto
surfaces in the room.
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\2\ Briefing memorandum from Kristina M. Hatlelid, Ph.D.,
M.P.H., Toxicologist, Directorate for Health Sciences, to the
Commission, ``Petition HP 00-3 to Ban Lead-cored Candle Wicks,''
December 12, 2000. This and other CPSC materials for this rulemaking
referenced in this preamble are available in PDF format on the CPSC
World Wide Web site at www.cpsc.gov. Select ``Library (FOIA),''
Electronic Reading Room--Freedom of Information Act Information,''
``2001 FOIA Information, and ``Commission Briefing Packages.'' Then
scroll down to the materials captioned ``Ban of Candle Wicks.''
\3\ Id.
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Several countries have acted on this issue. Officials in Canada
issued an advisory in January, 2001, warning consumers that some
candles sold in Canada contained lead-cored wicks, and offering advice
on making informed purchasing decisions.\4\ Officials in Australia and
New Zealand have instituted provisional bans on candles with wicks
containing any amount of lead.\5\ Australia is now considering making
the ban permanent.
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\4\ Health Canada Advisory 2001-02, January 2001.
\5\ Commonwealth of Australia Consumer Protection Notice No. 11
of 1999 under the Trade Practices Act of 1974, September 1999; New
Zealand Ministry of Consumer Affairs Unsafe Goods Notice under the
Fair Trading Act 1986, June 2000.
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Denmark issued a more comprehensive order in December 2000 banning
a number of products containing lead.\6\ Chafing dish candles and other
candles are specifically included in the ban. The order defines a lead-
containing product as one in which lead represents more than 50 mg/kg
(0.005 percent) of the homogeneous components.
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\6\ Danish Environmental Protection Agency Ministry of
Environment and Energy Council Directive 89/677/EEC and implementing
orders.
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D. Statutory Authority
This proceeding is conducted under provisions of the FHSA. 15
U.S.C. 1261-1278. It involves three actions. First, pursuant to section
3(a) of the FHSA, the Commission is proposing to declare that metal-
cored candle wicks containing more than 0.06 percent lead by weight of
the metal and candles with such wicks are hazardous substances.
(Proposed 16 CFR 1500.12(a)(2)). Second, pursuant to section 2(q)(1)(B)
of the FHSA, the Commission is proposing to ban such wicks and candles
with such wicks. (Proposed 16 CFR 1500.17(a)(13)). Third, pursuant to
section 10(a) of the FHSA, the Commission is proposing to require that
manufacturers and importers of metal-cored wicks and candles test and/
or maintain records of testing performed by the supplier of the metal-
cored wicks or the metal used in the metal cores. Id. The testing
records must demonstrate compliance for the lots of wicks and/or
[[Page 20064]]
candles and must maintain a line of continuity between the two.
The Commission is proposing to declare that metal-cored candle
wicks containing more than 0.06 percent lead by weight of the metal and
candles with such wicks are ``hazardous substances'' within the meaning
of section 2(f)(1)(A) of the FHSA because they are toxic, and ``may
cause substantial personal injury or substantial illness during or as a
proximate result of any customary or reasonably foreseeable handling or
use * * *.'' 15 U.S.C. 1261(f)(1)(A). A proceeding to classify a
substance as a hazardous substance under section 3(a) of the FHSA is
governed by, inter alia, sections 701(e), (f), and (g) of the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 371(e)-(g). See 15
U.S.C. 1262(a)(2).
Under section 2(q)(1)(B) of the FHSA, the Commission may classify
as a ``banned hazardous substance'' any hazardous substance intended
for household use which, notwithstanding the precautionary labeling
required by the FHSA, presents such a hazard that keeping the substance
out of interstate commerce is the only adequate means to protect the
public health and safety. 15 U.S.C. 1261(q)(1)(B). A proceeding to
classify a substance as a banned hazardous substance under section
2(q)(1)(B) of the FHSA is governed by the requirements set forth in
section 3(f) of the FHSA, and by sections 701(e), (f), and (g) of the
Federal Food, Drug, and Cosmetic Act (``FDCA'') (21 U.S.C. 371(e)). See
15 U.S.C. 1261(q)(2) and 1262(f).
The February 20, 2001, ANPR was the first step necessary to declare
the specified candle wicks and candles to be banned hazardous
substances under section 2(q)(1). See 15 U.S.C. 1262(f). The proposed
regulations issued today continue the regulatory process in accordance
with the requirements of 15 U.S.C. 1262(a) and (h). Under the rules
proposed today, metal-cored candle wicks containing more than 0.06
percent lead by weight of the metal and candles with such wicks would
be declared to be hazardous substances and would be banned.
If the Commission proceeds to issue a final rule banning these
wicks and candles, it must publish the text of the final rule and a
final regulatory analysis that includes: (1) A description of the
potential costs and benefits of the rule; (2) A description of
alternatives considered by the Commission (including a description of
their potential costs and benefits and an explanation of why they were
not chosen); and (3) a summary of significant issues raised by comments
on the preliminary regulatory analysis published with these proposed
rules. 15 U.S.C. 1262(i)(1). The Commission also must make findings
that: (1) any relevant voluntary standard is unlikely to adequately
reduce the risk of injury or substantial compliance with the voluntary
standard is unlikely; (2) the expected benefits of the regulation bear
a reasonable relationship to expected costs; and (3) the regulation
imposes the least burdensome requirement that would adequately reduce
the risk of injury. 15 U.S.C. 1262(i)(2).
Procedures established by section 701(e) of the FDCA would govern
Commission action to finalize the hazardous substance declaration and
the banning rule. 15 U.S.C. 1262(a)(2) and 1261(q)(2). These procedures
provide that once the Commission issues a final rule, persons who would
be adversely affected by the rule have a period of thirty (30) days in
which to file objections stating reasonable grounds therefor, and to
request a public hearing on those objections. 21 U.S.C. 371(e). Should
valid objections be filed, a hearing to receive evidence concerning the
objections would be held and the presiding officer would issue an order
after the hearing, based upon substantial evidence. 21 U.S.C. 371(e);
16 CFR part 1502.
E. Response to Comments on the ANPR
Eleven comments were received in response to the ANPR. Nine
comments were in favor of the proposal to ban lead-cored wicks. One
commenter opposed forcing companies to compensate for parents who are
not preventing their children from being exposed to lead emissions from
such wicks. One commenter opposed a mandatory rule and submitted a
voluntary standard that would ban the use of domestically produced
metal-cored wicks containing greater than 0.01 percent lead and
imported wicks with metal cores, irrespective of lead content. The
issues raised by commenters and the Commission responses to them are
discussed below.
1. Federal Regulation
Comments: Nine of the eleven comments support the proposal to ban
lead-cored wicks. One dissenting comment from a consumer stated that
the candle industry should not be made to bear the burden for parents
who do not adequately protect their children. One commenter,
representing a standards organization, submitted a voluntary standard
to take the place of a mandatory rule. About half of the commenters,
including a representative of the National Candle Association (NCA),
stated that a voluntary standard would not adequately remove lead-cored
wicks from commerce.
Response: The CPSC does not believe it is reasonable to expect that
parents alone can protect children from all consumer product hazards,
especially if potential hazards are not readily apparent. The
Commission believes that a mandatory standard is necessary, in part
because of the failure of the industry to maintain conformance with a
voluntary commitment to eliminate lead wicks made in 1974, and
recognizes that the NCA and its member firms support the development of
the mandatory rule.
A mandatory standard would: (1) Apply to all domestic and imported
candle and wick products containing metal-cored wicks regardless of a
company's membership in a trade organization or knowledge of applicable
standards; (2) deter manufacturers from making non-conforming wicks or
candles and enable the staff to seek civil penalties for violations;
(3) increase compliance by retailers and distributors who often require
that products meet applicable federal standards; and (4) through
cooperative efforts with the U.S. Customs Service, prevent non-
complying products from entering the U.S.
2. Voluntary Standards
Comment: Voices of Safety International (VOSI) proffered a
voluntary standard for lead in candle wicks, specifying that
domestically produced metal-cored wicks contain no more than 0.01
percent lead in the metal. The standard further specifies that imported
candle wicks may not contain metal cores. The VOSI standard includes a
methodology, based on tensile strength of metals, for determining
whether metal-cored wicks comply with the specified maximum lead
content. VOSI also asserted that the provision of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, concerning adoption of voluntary consensus
standards by federal agencies applies to this proceeding.
Response: The CPSC staff analysis of the submitted standard
uncovered a number of difficulties concerning the scope of the
standard, the proposed tensile test methodology, and the acceptance of
the standard by the intended industry. The Commission thus finds
preliminarily that the VOSI standard is not likely to result in the
elimination or adequate reduction of the risk at issue in this
proceeding and that substantial compliance with it is
[[Page 20065]]
unlikely. See a more detailed discussion of the bases for these
findings in Section F.2, Voluntary Standards, below.
VOSI's assertion that the NTTAA applies to this proceeding is
incorrect. Office of Management and Budget (OMB) Circular A-119
expressly excludes from the NTTAA requirements ``independent regulatory
commissions insofar as they are subject to separate statutory
requirements regarding the use of voluntary consensus standards,'' as
is the Commission under the FHSA. Federal Participation in the
Development and Use of Voluntary Consensus Standards and in Conformity
Assessment Activities, OMB Circular A-119, February 10, 1998, at
section 5.
3. Health Effects
Comments: A number of commenters reiterated the harmful effects of
lead exposure in children and the potential for lead exposure from
candles.
Response: As discussed above, the toxic effects of lead and the
risk to consumers, especially children, from exposure to lead emitted
from lead-cored wick candles were presented in the initial CPSC staff
briefing package on Petition No. HP 00-3.\7\
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\7\ See fn. 2 above.
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4. Substitute Materials
Comments: Three commenters discussed available substitutes and
their use by manufacturers. Three commenters reiterated that other
countries have issued bans on the import and sale of lead-containing
wicks. The National Candle Association stated that use of lead-cored
wicks has been broadly discontinued domestically, and that zinc-cored
wicks currently in use would comply with a ban on metal-cored wicks
exceeding 0.06 percent lead by weight in the metal. One commenter
claimed that paper- or cotton-cored wicks would not be acceptable
because they are less rigid than zinc and have a higher burning rate.
Response: The CPSC staff economic analysis supports the proposition
that alternatives to the use of lead core are available. The staff
believes that no wick manufacturer in the U.S. currently uses lead core
in the production of its wicks. The Commission preliminarily concludes,
based on that analysis, that the cost to manufacturers or consumers of
a ban on lead-cored wicks would be small.
The CPSC staff has found no basis for the commenter's claim that
paper-or cotton-cored wicks are unacceptable alternatives to lead-cored
wicks.
As discussed above, Canada, Australia, New Zealand, and Denmark
have acted on this issue, limiting the use of lead in candle wicks or
providing guidance to consumers.
5. Metal-Cored Wicks
Comments: Two commenters expressed concern about the presence of
even small amounts of lead in metal-cored wicks.
Response: Metals, such as zinc, may be used in candle wicks. The
lead content of the zinc used in zinc-cored wicks has been determined
by CPSC and others to range from about 0.0005 percent to 0.06 percent
by weight in the metal.\8\ CPSC laboratory and other tests have shown
no detectable levels of airborne lead emissions from candles with metal
wicks containing 0.06 percent lead or less by weight. Therefore, the
Commission is proposing a ban on metal-cored wicks containing more than
0.06 percent lead by weight in the metal and candles with such wicks,
but is not proposing to limit the use of metal cores that contain 0.06
percent lead or less.
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\8\ See fn. 2 above.
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6. Labeling
Comments: Three commenters believe that regulating lead-cored wick
candles by requiring warning labels would not adequately protect public
health, and one commenter suggested that candles that comply with the
proposed 0.06 percent maximum lead limit should be labeled with that
information.
Response: The CPSC agrees that lead-cored wicks and candles
containing lead-cored wicks should be banned and that precautionary
labeling is not an acceptable strategy for protecting vulnerable
populations from lead poisoning that may be induced by burning candles
with lead-cored wicks.\9\ The Commission does not believe that
requiring individual complying candles to be labeled would add to the
safety of these products.
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\9\ Memorandum from Carolyn Meiers, Engineering Psychologist,
Human Factors, to Kristina Hatlelid, Ph.D., M.P.H., Directorate for
Health Sciences, ``Labeling of Candles with Lead-cored Wicks
(Petition HP 00-3),'' October 18, 2000. See fn. 2 above for
information on the availability of this and other related documents
on the Internet and at the CPSC reading room.
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The proposed rule would require labeling of each shipping container
of metal-cored wicks, and each shipping container of candles with
metal-cored wicks, with the statement ``Conforms to 16 CFR
1500.17(a)(13)'' and a number or other designation that relates back to
the test results demonstrating compliance for the wicks/candles in that
shipping container. CPSC specifically invites interested parties to
comment on this feature of the proposal.
F. Alternatives to Proposed Ban
1. No Action
If the Commission took no action, lead-cored candle wicks could
continue to be sold in the U.S. In the mid-1970's the domestic candle
industry stopped using lead in wicks, but lead-cored wicks reappeared
on the domestic market some time thereafter. While the domestic
industry states that it has now voluntarily eliminated lead in their
wicks, imports may continue to be a source of lead in the absence of a
mandatory standard. Under the no action scenario, CPSC enforcement
staff would be limited to taking action against lead-containing wicks
under the FHSA on a case-by-case basis.
2. Voluntary Standards
In 1974, the Candle Manufacturers Association industry group
submitted a statement informing the Commission of an agreement among
candle manufacturers to convert to substitutes for lead-cored wicks in
candles by the end of the third quarter 1974. They also agreed not to
import candles with lead-cored wicks. Further, the major domestic wick
manufacturer at that time agreed to discontinue the production of lead-
cored wicks.
Despite this agreement, some wick manufacturers resumed producing
lead-cored wicks and some candle manufacturers resumed producing and
importing candles with lead-cored wicks after 1974.
In May 2000, a task group for candle wicks was formed under the
ASTM F15.45 Candle Products Subcommittee to develop a consensus
standard to address the lead content of candle wicks. The task group
stopped their standards development process in February 2001 in favor
of supporting the CPSC mandatory rulemaking process.
During the public comment period on the ANPR, VOSI proffered a
voluntary standard for lead in candle wicks. The VOSI standard
specifies that metal-cored wicks may contain no more than 0.01 percent
lead in the metal. The standard further specifies that imported candle
wicks may not contain metal cores. The standard includes a methodology,
based on tensile strength of metals, for determining whether metal-
cored wicks comply with the specified maximum lead content.
CPSC technical staff reviewed the standard and noted a number of
difficulties. Although the standard states that a maximum of 0.01
percent
[[Page 20066]]
lead is required to protect consumer health, no technical or health
basis for this level is provided. The CPSC staff maintains that the
proposed limit of 0.06 percent lead by weight in the metal is
appropriate and supported by the laboratory analyses performed by CPSC
staff and others.
The CPSC staff further states that the analytical methodology in
the submitted standard is not capable of reliably determining either
the presence or concentration of lead in metal-cored candle wicks. The
CPSC staff concludes that the tensile strength of a metal alloy would
not definitively identify zinc cored wicks with less than the maximum
allowable lead content in the metal, but could falsely detect alloys
not containing lead, causing them to fail the test and be needlessly
prohibited from wick use. The staff states that the metal's lead
content, not its physical attributes, is the important characteristic
in protecting consumers' health.
The VOSI standard specifies different standards for domestic and
imported products. Specifically, the standard specifies that
domestically produced metal-cored wicks may contain no more than 0.01
percent lead in the metal but that imported candle wicks may not
contain metal cores. The FHSA gives CPSC the authority to regulate
hazardous substances. In the absence of evidence that a specific type
of metal wick meets the definition of a hazardous substance under the
FHSA, the CPSC cannot ban it. Furthermore, a discriminatory approach to
imports with no basis in fact would in all likelihood be a violation of
the North American Free Trade Agreement (NAFTA), if not other U.S.
treaty obligations.
The Commission believes that membership in standards organizations,
such as ASTM, serves, in part, to transmit applicable standards to
member firms. VOSI has offered no information that its members include
candle or wick manufacturers. VOSI has not shown that the standard was
developed within an industry consensus framework or is otherwise widely
known to candle and wick manufacturers in the United States or
elsewhere.\10\ Nor has it provided any evidence that there would be
substantial compliance with the voluntary standard.
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\10\ As of January 16, 2002, The VOSI world wide web site
states, with respect to the candle wick standard, that ``These
standards have been approved by VOSI and are for reference only.''
That page of the website goes on to provide for ongoing public
review of ``Approved VOSI Public Health Standards.''
Section 3(i)(2) of the FHSA requires that a voluntary standard
be ``adopted and implemented'' before the Commission must defer to
it rather than promulgating a mandatory standard. Thus, based on
VOSI's public statements on the status of its candle wick standard,
the Commission would also be justified in eliminating it from
further consideration in this rulemaking without reaching its
technical and procedural flaws. 15 U.S.C. 1262(i)(2).
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Based on the foregoing analysis, the Commission finds that the VOSI
standard is technically unsound, and thus would not result in the
elimination or adequate reduction of the risk, and that substantial
compliance with it is unlikely.
Even if a technically valid voluntary standard were developed, the
Commission maintains that a mandatory standard is necessary to
adequately protect public health.
3. Precautionary Labeling
A CPSC Human Factors staff analysis concludes that precautionary
labeling of individual candles is not an acceptable strategy for
protecting vulnerable populations from lead poisoning that may be
caused by burning candles with lead-cored wicks.\11\
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\11\ See fn. 9.
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That analysis shows that since lead is emitted from a candle when
the candle is used as intended, the only preventative measures
consumers could take to protect themselves against the hazard would be
to not burn candles with lead-cored wicks. No label or subsequent
action by the consumer would prevent the release of lead into the air
if the candle is used as intended. The staff analysis therefore
concludes that it is not realistic to expect consumers to comply with a
warning label advising not to burn the candles, but to use them only
for decorative purposes.\12\
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\12\ Id.
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G. Comment Period
In accordance with section 4 of Executive Order 12889 implementing
NAFTA, the Commission is providing a 75 day public comment period on
the proposed rules. The Commission is particularly interested in
acquiring additional data on the effect the proposed rules would have
on prices to consumers and costs to wick and candle manufacturers.
H. Preliminary Regulatory Analysis
1. FHSA Requirement
The Commission has preliminarily determined to issue a rule
declaring a ban on metal-cored wicks containing more than 0.06 percent
lead by weight in the metal and candles with such wicks. Section 3(h)
of the FHSA requires that the Commission prepare a preliminary
regulatory analysis for this action. 15 U.S.C. 1261(h). The following
discussion addresses this requirement.
2. Introduction
The Commission is considering amending the FHSA regulations to
declare that metal-cored wicks containing more than 0.06 percent lead
by weight in the metal and candles with such wicks are hazardous
substances and to ban such wicks and candles. In February 2001, the
Commission voted to issue an ANPR that could lead to such a declaration
and ban. 66 FR 10863. On April 17, 2002, the Commission voted to issue
proposed rules declaring that such wicks and candles with such wicks
are hazardous substances and banning them.
3. Required Content of the Regulatory Analysis
To accomplish rulemaking under the FHSA, the Commission must
publish preliminary and final regulatory analyses containing a
discussion of various factors. These factors include a description of
the potential benefits and potential costs of the rule, including any
benefits and costs that cannot be quantified in monetary terms, and an
identification of those most likely to receive the benefits and bear
the costs. The FHSA also requires a description of any reasonable
alternatives to the rule, together with a summary description of their
costs and benefits, and a brief explanation of why such alternatives
were not chosen. 15 U.S.C. 1262(h) and 1262(i). In addition, the
Commission must address the requirements of the Regulatory Flexibility
Act, which considers effects on small firms, and the requirement for
review pursuant to the National Environmental Policy Act.
4. Analysis of Proposed Hazardous Substance Declaration/Ban \13\
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\13\ The following discussion of potential costs and potential
benefits of the proposed rules is extracted from Memorandum from
Mary F. Donaldson, CPSC Directorate for Economic Analysis to
Kristina Hatlelid, CPSC Directorate for Health Sciences,
``Preliminary Regulatory Analysis of a Proposed Ban of Lead in
Candlewicks,'' March 5, 2002. See fn. 2 above for information on the
availability of this and other related documents on the Internet and
at the CPSC reading room.
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(a) Potential Benefits
The benefits to consumers of eliminating lead-cored wicks as a
source of lead exposure are not quantifiable. Nonetheless, the proposed
ban may result in positive health benefits in individual cases, and
will contribute to the gradual reduction in lead exposure to the U.S.
population. Additionally, the Commission did not regulate
[[Page 20067]]
candlewicks in the mid-1970s because the industry voluntarily agreed to
eliminate lead from candlewicks. A ban of the use of lead in
candlewicks will therefore help ensure that lead will not be used in
candlewicks in the future.
(b) Potential Costs
The costs of replacing lead-cored candlewicks with non-leaded wicks
are expected to be small. The current use of lead in wicks is already
small, since none of the NCA members use lead in their wicks beyond the
acceptable trace levels found in zinc cores, and information obtained
from an industry source indicates that the cost of substitutes for
lead-cored wicks is not higher than the cost of wicks made with lead.
In fact, when lead-cored candlewicks were available, they cost more per
yard than candlewicks made with other materials.
However, there are some costs associated with testing, tracking,
maintaining records of candles and candlewicks with metal cores, and
labeling of shipping containers. The proposed rule requires firms that
manufacturer, import, or otherwise distribute metal-cored candlewicks
and candles perform testing or obtain records of testing to assure
compliance. Records of testing would have to bear a lot designation
that relates to the candles and candlewicks and be retained for as long
as the product the testing pertains to is being distributed plus three
years. In addition, firms would have to label shipping containers.
Based on discussions with representatives of the candle and
candlewick industries, the metal-cored wick testing burden will likely
be minimal for domestic manufacturers of candles and candlewicks,
because most candlewicks used in the U.S. are produced by a small
number of manufacturers, and the testing of the metal used in the wicks
already takes place in the course of manufacturing of the metal used in
the wire. The recordkeeping associated with the testing may demand,
from candlewick manufacturers and distributors, as much as 40 hours per
metal candlewick lot produced annually. From a discussion with a
representative of the industry, there may be 5 to 15 lots of wire used
in candlewick production per year. Recordkeeping by the domestic
candlewick manufacturers and distributors may require as much as 200 to
600 hours per year.
Developing a tracking system for lots may involve some costs.
Candle and candlewick manufacturers would have to keep track of when
lot numbers for wicks with metal cores changed, and adjust any existing
identification system to reflect this. According to the National Candle
Association, lot identification might be somewhat problematic for the
industry.
Importers would also have to obtain appropriate test results, and
develop a system of identification in order to track test results with
shipments. The differences in the costs of the testing and labeling
requirements for importers, relative to domestic candle manufacturers,
are not clear, but it seems likely that the coordination of testing and
labeling would be somewhat more complex for importers and therefore
more costly, since candles are imported from many countries. One large
importer did not think the impact of the rule would be substantial, but
was unable to describe how the testing requirements would affect costs.
Domestic producers, distributors, private labelers, and importers
of candles, as well as importers of candlewicks, would not have to
conduct tests as long as they maintain copies of prior test results for
metal candlewicks. Recordkeeping may require as much as 40 hours per
firm per year. The exact number of manufacturers and importers is not
known and not every firm uses metal-cored wicks. If there are 460
domestic producers of candles in the U.S., and an equivalent number of
importers of candles and candlewicks, and if we assume that half of all
manufacturers and importers have metal in their candlewicks, then the
estimated number of hours for complying with the recordkeeping
requirements of the rule for these firms could be as high as 18,400
hours. The total estimated annual employee compensation cost for the
paperwork burden may be as high as $400,000, industry wide.
For most candle producers, the costs of labeling are likely to be
small. The majority of candles are not produced with metal-cored wicks
and therefore will not need to be labeled. Additionally, the labeling
requirements will add little to the cost of manufacturing candles when
labels are needed if existing labeling machines can be used to add the
information required by the rule's labeling requirements.
Although the labeling costs are likely to be low, we can estimate
the number of boxes of candles that might be affected. If we assume
that $270 to $540 million in candle shipments are affected (i.e., 15-30
percent of all candles shipped with metal wicks), and that each
shipping container holds 144 candles (i.e., 12 boxes of a dozen
candles), perhaps 2 to 4 million shipping containers would need to be
labeled annually. If a label costs 5 to 10 cents (not including the
initial purchase of the labeling machine), then $100,000 to $400,000 in
annual costs would be absorbed by the candle industry for labeling.
Combined, labeling and recordkeeping may cost the candle industry
about $500,000 to $800,000 per year. On a percentage basis, these costs
would represent a small fraction (about 0.03 to 0.04 percent) of the
overall value of candle shipments which, in 1999, was about $1.8
billion.
Finally, there might also be some costs associated with inventories
of uncertified or non-complying candlewicks held by candle
manufacturers. These candlewicks would have to be certified or scrapped
under the standard. The proposed rule would apply to candles and
candlewicks manufactured after the rule's effective date. Although non-
complying candlewicks may have been manufactured prior to the effective
date, they would not be usable in candles manufactured after the
effective date. It is not anticipated, however, that a large amount of
candlewick inventory will be affected.
One possible impact of the rule is the movement away from the use
of metal core wicks due to the added burden of recordkeeping, labeling
and testing. Based on discussions with several candle manufacturers,
this has already started to occur. Manufacturers desiring to eliminate
metal-cored wicks would have to perform product testing to find a
suitable substitute wick for the candle design. The cost of the
substitute wick material will not likely be a significant factor in the
decision to change wicks because candle wicks are a very low cost item
that do not vary much by type. Based on compliance cost and performance
factors, each firm will decide whether they will continue to use metal-
cored wicks in their candles.
It is anticipated that the costs of the rule, although small, will
be absorbed by both consumers and suppliers (including manufacturers
and importers). Costs associated with the initial implementation of the
rule are likely to be borne by the suppliers. These start-up costs will
not likely be passed on to consumers, because the costs may not be
uniform across the industry. Some firms may have to develop tracking
systems for lot identification, acquire additional labeling machinery,
and certify or scrap old candlewicks. Costs associated with ongoing
compliance with the rule are expected to be small and these costs will
likely be passed along to the consumer in the form of higher prices.
[[Page 20068]]
The actual amount of these costs is not clear at this time.
In summary, while the benefits of a ban of lead in candlewicks are
likely to be small, the costs of the ban are also small. The action
will, however, contribute to the gradual reduction in lead exposure in
the U.S. population.
5. Alternatives to the Rule
The Commission has considered several other alternatives,
including: no action, product labeling and deferral to a voluntary
standard. See discussion above at Section F., Alternatives to Proposed
Ban.
I. Paperwork Reduction Act
The proposed ban regulation will require manufacturers and
importers of metal-cored candle wicks and candles with such wicks to
perform testing or obtain records of testing, maintain records, and
label shipping containers for metal-cored candle wicks and candles with
such wicks that they produce or import. For this reason, the rule
proposed below contains ``collection of information requirements,'' as
that term is used in the Paperwork Reduction Act, 44 U.S.C. 3501-3520.
Therefore, the proposed rule is being submitted to the Office of
Management and Budget (``OMB'') in accordance with 44 U.S.C. 3507(d)
and implementing regulations codified at 5 CFR 1320.11.
Based on estimates made in the course of developing the metal-cored
candle wick standard and on information obtained from industry sources,
the Commission estimates that complying with the recordkeeping
requirements of the proposed banning rule will require approximately 40
hours per metal-cored candle wick lot produced annually. The CPSC staff
does not anticipate that domestic producers or distributors of metal-
cored candle wicks will conduct testing, since the content of the metal
wire used in the candle wicks is analyzed in the course of the
manufacturing of the metal. These analyses are provided routinely by
the manufacturers of the wire. Since 5 to 15 lots of metal-cored candle
wicks are produced per year in the U.S., recordkeeping by domestic
metal-cored wick manufacturers under the regulation as proposed would
require no more than an estimated 200 to 600 hours per year.
The exact number of manufacturers and importers of candles and of
importers of candle wicks is not known. Not every producer/importer
uses metal-cored wicks in its candles. CPSC staff estimates that there
may be as many as 460 domestic producers of candles. If there are an
equivalent number of importers of candles/candle wicks and it is
assumed that half of all these manufacturers and importers have metal
in their candle wicks, then the estimated number of hours annually that
would be expended by these entities for complying with the
recordkeeping requirements of the rule may be as high as 18,400.
Combining these two estimates, the estimated total burden on metal-
cored wick producers and producers/importers of candles with metal-
cored wicks would be 18,600 to 19,000 hours per year.
OMB may comment to CPSC between 30 and 60 days after the
publication of the proposed banning rule. Therefore, although OMB will
accept comments until June 24, 2002, a comment will be assured of
having its maximum effect if it is filed by May 24, 2002.
Comments to OMB should be directed to the Desk Officer for the
Consumer Product Safety Commission, Office of Information and
Regulatory Affairs, OMB, Washington, DC 20503; telephone (202) 395-
7340. The Commission encourages commenters to provide copies of such
comments to the Commission's Office of the Secretary, with a caption or
cover letter identifying the materials as comments submitted to OMB on
the proposed rule to ban certain metal-cored candle wicks and candles
with such wicks.
J. Regulatory Flexibility Act Certification
When an agency undertakes a rulemaking proceeding, the Regulatory
Flexibility Act (RFA), as amended by the Small Business Regulatory
Enforcement Fairness Act of 1996, 5 U.S.C. 601 et seq., generally
requires the agency to prepare initial and final regulatory flexibility
analyses describing the impact of the rule on small businesses and
other small entities. Section 605 of the RFA provides that an agency is
not required to prepare a regulatory flexibility analysis if the head
of an agency certifies that the rule will not have a significant
economic impact on a substantial number of small entities.
The Commission's Directorate for Economic Analysis prepared a
preliminary assessment of the impact of a rule to declare that metal-
cored wicks containing more than 0.06 percent lead by weight in the
metal and candles with such wicks are hazardous substances and to ban
such wicks and candles. A copy of the preliminary analysis is available
for inspection in the docket for this rulemaking. The assessment
reports that the costs to consumers and candle wick and candle
manufacturers are likely to be small.
At present, the Commission does not have quantitative information
on the number of small businesses that might be affected by the
proposed rules, although we believe that almost all domestic candle and
candle wick manufacturers are small. The staff assessment concludes
that because the incremental cost of the proposals is likely to be
small, it is unlikely that the proposals will have a substantial effect
on a significant number of small businesses.
The Commission requests comment from companies that supply candle
wicks and candles that would be affected by these proposed rules. The
Commission is particularly interested in information on the likely
effect on small businesses of the testing, recordkeeping, and shipping
container labeling requirements of the proposed banning rule.
Based on the foregoing assessment, the Commission certifies that
the rules to declare that metal-cored wicks containing more than 0.06
percent lead by weight in the metal and candles with such wicks are
hazardous substances and to ban such wicks and candles, if promulgated
in final form as proposed, would not have a significant adverse impact
on a substantial number of small businesses or other small entities.
K. Environmental Considerations
Pursuant to the National Environmental Policy Act, and in
accordance with Council on Environmental Quality regulations and CPSC
procedures for environmental review, the Commission has preliminarily
assessed the possible environmental effects associated with the
proposed hazardous substance declaration and ban for metal-cored candle
wicks containing more than 0.06 percent lead by weight of the metal and
candles with such wicks.
The Commission's regulations at 16 CFR 1021.5(c)(1) state that
rules or safety standards to provide design or performance requirements
for products normally have little or no potential for affecting the
human environment. Preliminary analysis of the impact of the rules
proposed today indicates that they will have no significant effects on
the environment. This would be especially true if the effective date of
the banning rule were to enable firms affected by the rule to deplete
any existing non-complying inventory. Thus, the Commission concludes
that no environmental assessment or environmental impact statement is
required in this proceeding.
[[Page 20069]]
L. Effective Date
The rule proposed today would provide a period of one-hundred
eighty (180) days for depletion of any existing stocks of candle wick
material and candles subject to the proposed ban. It would then apply
to any metal-cored candle wick containing more than 0.06 percent lead
by weight in the metal, and any candle with such a wick, that is
manufactured or imported on or after that date.
M. Executive Order 12988
As provided for in Executive Order 12988 (February 5, 1996), the
CPSC states the preemptive effect of these proposed regulations as
follows.
The FHSA provides that, generally, if the Commission issues a
banning rule under section 2(q) of the FHSA to protect against a risk
of illness or injury associated with a hazardous substance, ``no State
or political subdivision of a State may establish or continue in effect
a requirement applicable to such substance and designed to protect
against the same risk of illness or injury unless such requirement is
identical to the requirement established under such regulations.'' 15
U.S.C. 1261n(b)(1)(B). Upon application to the Commission, a State or
local standard may be excepted from this preemptive effect if the State
or local standard (1) provides a higher degree of protection from the
risk of injury or illness than the FHSA standard and (2) does not
unduly burden interstate commerce. In addition, the Federal government,
or a State or local government, may establish and continue in effect a
non-identical requirement that provides a higher degree of protection
than the FHSA requirement for the hazardous substance for the Federal,
State or local government's own use. 15 U.S.C. 1261n(b)(2). Thus, with
the exceptions noted above, the proposed rule banning metal-cored
candle wicks containing more than 0.06 percent lead by weight of the
metal and candles with such wicks would preempt non-identical state or
local requirements applicable to such wicks and candles designed to
protect against the same risk of injury.
N. Trade Secret or Proprietary Information
Any person responding to this notice who believes that any
information submitted is trade secret or proprietary should
specifically identify the exact portions of the document claimed to be
confidential. The Commission's staff will receive and handle such
information confidentially and in accordance with section 6(a) of the
Consumer Product Safety Act (CPSA), 15 U.S.C. 2055(a). Such information
will not be placed in the public docket for the rulemaking and will not
be made available to the public simply upon request. If the Commission
receives a request for disclosure of the information or concludes that
its disclosure is necessary to discharge the Commission's
responsibilities, the Commission will inform the person who submitted
the information and provide that person an opportunity to present
additional information and views concerning the confidential nature of
the information. 16 CFR 1015.18(b) (1999).
The Commission's staff will then make a determination of whether
the information is trade secret or proprietary information that cannot
be released. That determination will be made in accordance with
applicable provisions of the CPSA; the Freedom of Information Act
(FOIA), 5 U.S.C. 552b; 18 U.S.C. 1905; the Commission's procedural
regulations at 16 CFR part 1015 governing protection and disclosure of
information under provisions of FOIA; and relevant judicial
interpretations. If the Commission concludes that any part of the
information that has been submitted with a claim that the information
is a trade secret or proprietary is disclosable, it will notify the
person submitting the material in writing and provide at least 10
calendar days from the receipt of the letter to allow for that person
to seek judicial relief. 15 U.S.C. 2055(a)(5) and (6); 16 CFR
1015.19(b).
O. Conclusion
For the reasons stated in this preamble, the Commission
preliminarily finds that metal-cored candle wicks containing more than
0.06 percent lead by weight in the metal and candles with such wicks
are hazardous substances, that cautionary labeling required by the FHSA
is not adequate for such wicks and candles, and that, due to the degree
and nature of the hazard presented by these items, in order to protect
the public health and safety it is necessary to keep them out of
commerce.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Reporting
and recordkeeping.
For the reasons stated in the preamble, the Commission proposes to
amend Title 16 of the Code of Federal Regulation to read as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND
ENFORCEMENT REGULATIONS.
1. The authority for part 1500 continues to read as follows:
Authority: 15 U.S.C. 1261-1278.
2. In Sec. 1500.12, add a new paragraph (a)(2) to read as follows:
Sec. 1500.12 Products declared to be hazardous substances under
section 3(a) of the act.
(a) * * *
(2) metal-cored candle wicks that have a lead content of more than
0.06 percent of the total weight of the metal core, and candles made
with such wicks.
3. In Sec. 1500.17, add a new paragraph (a)(13) to read as follows:
Sec. 1500.17 Banned hazardous substances.
(a) * * *
(13)(i) Candles made with metal-cored wicks. Lots of candles
manufactured or imported on or after ________ __, 2002 [insert date 180
days after promulgation of final rule] made with metal-cored candle
wicks, unless:
(A) The metal core of each candle wick has a lead content
(calculated as the metal) of not more than 0.06 percent of the total
weight of the metal core;
(B) The manufacturer, importer, private labeler, or distributor of
each lot of candles with metal-cored wicks conducts, or obtains a
report of the results of, reasonable and representative tests on either
the candles in that lot, the metal-cored candle wicks used in that lot
of candles, or the metal used to produce the wicks that were used in
that lot of candles, that establish that the lead content of the metal
used in the wicks is not more than 0.06 percent (of the total weight of
the metal core);
(C) The records of such testing are in English, identify each lot
of candles to which the test results apply, identify all numbers or
other designations used to represent each lot on the label of
containers as required in paragraph (a)(13)(i)(D) of this section, are
maintained in the United States for as long as the candles the testing
pertains to are being distributed plus three (3) years, and are made
available for inspection and copying within 48 hours of a request by
any officer, employee, or agent acting on behalf of the Consumer
Product Safety Commission; and
(D) Each outer container or wrapper in which candles from a lot
subject to paragraphs (a)(13)(i)(B) and (a)(13)(i)(C) of this section
are shipped, including each outer container or wrapper of such candles
distributed to a retail outlet, is
[[Page 20070]]
labeled ``Conforms to 16 CFR 1500.17(a)(13)'' and bears a number or
other designation that relates back to the test results for that lot.
For purposes of this paragraph (a)(13)(i)(D), the term ``outer
container or wrapper'' does not include the immediate container in
which candle(s) is/are intended to be displayed at retail or during use
in the home, unless that container or wrapper is also the only
container or wrapper in which the candle(s) is/are shipped to a
retailer. For purposes of this paragraph (a)(13)(i)(D), a lot of metal-
cored wick candles shall consist of all of the candles covered by any
report of testing required by paragraph (a)(13)(i)(B) of this section.
(ii) Metal-cored candle wicks. Lots of metal-cored candle wicks
manufactured or imported on or after ________ , ____ 2002 [insert date
180 days after promulgation of final rule] unless:
(A) The metal core of each candle wick has a lead content
(calculated as the metal) of not more than 0.06 percent of the total
weight of the metal core;
(B) The manufacturer, importer, private labeler, or distributor of
each lot of metal-cored candle wicks conducts, or obtains a report of
the results of, reasonable and representative tests on either the
candle wicks in that lot, or on the metal used to produce the wicks
that were used in that lot, that establish that the lead content of the
metal used in the wicks is not more than 0.06 percent (of the total
weight of the metal core);
(C) The records of such testing are in English, identify each lot
of candle wicks to which the test results apply, identify all numbers
or other designations used to represent each lot on the label of
containers as required in paragraph (a)(13)(ii)(D) of this section, are
maintained in the United States for as long as the candle wicks the
testing pertains to are being distributed plus three (3) years, and are
made available for inspection and copying within 48 hours of a request
by any officer, employee, or agent acting on behalf of the Consumer
Product Safety Commission; and
(D) Each outer container or wrapper in which candle wicks from a
lot subject to paragraphs (a)(13)(ii)(B) and (a)(13)(ii)(C) of this
section are shipped, including each outer container or wrapper of such
candle wicks distributed to a retail outlet, is labeled ``Conforms to
16 CFR 1500.17(a)(13)'' and bears a number or other designation that
relates back to the test results for that lot. For purposes of this
paragraph (a)(13)(ii)(D), the term ``outer container or wrapper'' does
not include the immediate container in which candle wick(s) is/are
intended to be displayed or sold at retail, unless that container or
wrapper is also the only container or wrapper in which the candle
wick(s) is/are shipped to a retailer. For purposes of this paragraph
(a)(13)(ii)(D), a lot of metal-cored wicks shall consist of all of the
candle wicks covered by any report of testing required by paragraph
(a)(13)(ii)(B) of this section.
(iii) Findings--(A) General. In order to issue a rule under section
2(q)(1) of the FHSA, 15 U.S.C. 1261(q)(1), classifying a substance or
article as a banned hazardous substance, the FHSA requires the
Commission to make certain findings and to include these in the
regulation. These findings are discussed in paragraphs (a)(13)(iii)(B)
through (D) of this section.
(B) Voluntary Standard. (1) One alternative to the ban that the
Commission considered is to take no mandatory action, and to depend on
a voluntary standard. One organization has a standard for candle wicks
intended to address the potential for substantial illness posed by such
wicks and candles with such wicks. The Commission has found that the
standard is technically unsound and that substantial compliance with it
is unlikely. Furthermore, there is no evidence that the standard has
been adopted and implemented by candle wick or candle manufacturers.
(C) Relationship of Benefits to Costs. The Commission estimates
that the ban will reduce the potential for exposure to lead and
resulting lead poisoning because there is no ``safe'' level of lead in
the blood. The annual cost to the candle/wick industry of the ban is
estimated by the Commission to be in the range of $500,000 to $800,000.
On a percentage basis these costs represent only 0.03 to 0.04 percent
of the overall value of candle shipments in 1999, which was
approximately $1.8 billion. Accordingly, the Commission finds that the
benefits from the regulation bear a reasonable relationship to its
costs.
(D) Least burdensome requirement. The Commission considered the
following alternatives: No action; labeling all metal-cored candles
with wicks containing more than 0.06 percent lead by weight of the
metal; and relying on the voluntary standard. Neither no action, nor
labeling, nor reliance on the voluntary standard would adequately
reduce the risk of illness. Therefore the Commission finds that a ban
on candle wicks containing more than 0.06 percent lead by weight of the
metal and candles with such wicks is the least burdensome requirement
that would prevent or adequately reduce the risk of illness.
Dated: April 18, 2002.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
The following documents contain information relevant to this
rulemaking, can be accessed on the World Wide Web at www.cpsc.gov,
and are available for inspection at the Office of the Secretary,
Consumer Product Safety Commission, Room 502, 4330 East-West
Highway, Bethesda, Maryland 20814:
1. Briefing memorandum from Kristina M. Hatlelid, Ph.D., M.P.H.,
Toxicologist, Directorate for Health Sciences, to the Commission,
``Petition HP 00-3 to Ban Lead-cored Candle Wicks,'' December 12,
2000.
2. Memorandum from K.M. Hatlelid, Ph.D., M.P.H., Toxicologist,
Directorate for Health Sciences, to Mary Ann Danello, Ph.D.,
Associate Executive Director, Directorate for Health Sciences,
``Review of Lead Emissions from Candles,'' November 15, 2000.
3. Memorandum from Carolyn Meiers, Engineering Psychologist,
Human Factors, to Kristina Hatlelid, Ph.D., M.P.H., Directorate for
Health Sciences, ``Labeling of Candles with Lead-cored Wicks
(Petition HP 00-3),'' October 18, 2000.
4. Briefing memorandum from Kristina M. Hatlelid, Ph.D., M.P.H.,
Toxicologist, Directorate for Health Sciences, to the Commission,
``Proposal to Ban Lead-Cored Candle Wicks,'' March 18, 2002.
5. Memorandum from Mary F. Donaldson, CPSC Directorate for
Economic Analysis to Kristina Hatlelid, CPSC Directorate for Health
Sciences, ``Preliminary Regulatory Analysis of a Proposed Ban of
Lead in Candlewicks,'' March 5, 2002.
[FR Doc. 02-9960 Filed 4-23-02; 8:45 am]
BILLING CODE 6355-01-P