[Federal Register Volume 68, Number 75 (Friday, April 18, 2003)]
[Rules and Regulations]
[Pages 19142-19148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9255]


=======================================================================
-----------------------------------------------------------------------

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500


Metal-Cored Candlewicks Containing Lead and Candles With Such 
Wicks

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Commission is today declaring that metal-cored candlewicks 
containing more than 0.06 percent lead by weight in the metal and 
candles with such wicks are hazardous substances and is banning such 
wicks and candles with such wicks.\1\ The Commission is issuing this 
final rule under authority of the Federal Hazardous Substances Act 
(FHSA).
---------------------------------------------------------------------------

    \1\ The Commissioners voted 3-0 to issue these final rules.

---------------------------------------------------------------------------
DATES: This final rule becomes effective on October 15, 2003.

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) 504-7254.

SUPPLEMENTARY INFORMATION:

A. Background

    On February 24, 2000, the U.S. Consumer Product Safety Commission 
(CPSC or Commission) received a request from Public Citizen 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 request from the National Apartment Association and the 
National Multi Housing Council. These requests were docketed 
collectively under the FHSA (Petition No. HP 00-3) on March 17, 2000.
    After analysis of the available data on lead-cored candlewicks and 
the information provided by the petitioners, the CPSC staff transmitted 
a briefing package to the Commission recommending that it proceed with 
a rulemaking that could result in a ban of lead-cored candlewicks and 
candles with such 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 voted to grant the petition and commence rulemaking by 
issuing an advance notice of proposed rulemaking (ANPR) incorporating 
this criterion. 66 FR 10863. The ANPR was followed in April of 2002 by 
a notice of proposed rulemaking (NPR) that included requirements for 
certification, record-keeping, labeling, and tracking of metal-cored 
candlewicks and candles that comply with the ban. 67 FR 20062.

B. The Product \2\
---------------------------------------------------------------------------

    \2\ Information presented in this preamble is derived from 
briefing memoranda to the Commission 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 Candlewicks,'' 
December 12, 2000; ``Proposal to Ban Lead-Cored Candlewicks,'' March 
18, 2002; and ``Briefing Package for Ban on Candles with Lead-
containing Wicks for Candle-making that Contain Lead--Final Rule,'' 
March 27, 2003. These and other materials for this rulemaking are 
available on the CPSC world wide Web site at www.cpsc.gov and from 
the CPSC office of the Secretary, Room 502, 4330 East West Highway, 
Bethesda, Maryland, 20814, (301) 504-7923.
---------------------------------------------------------------------------

    Lead-cored wicks are candlewicks 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 Market

1. Trade Associations

    The major trade association that represents candle and wick 
manufacturers and suppliers is the National Candle Association (NCA). 
NCA members include about 74 candle manufacturers, 10 of which are 
foreign. The NCA states that its members produce about 90 percent of 
the candles made in the U.S. Another U.S. based organization, comprised 
of craftspersons, is the International Guild of Candle Artisans, with 
800 members from around the world.

2. Candle Information

    Of 483 firms identified by CPSC staff as U.S. candle manufacturers, 
all but three firms had fewer than 500 employees and 293 (or 60 
percent) had fewer than five employees.
    In 2000, the latest year for which factory shipment data are 
available, U.S. domestic candle shipments totaled approximately $1.5 
billion. Imports

[[Page 19143]]

amounted to $504 million in 2000 with candles from the Far East 
accounting for almost half of the imports. U.S. exports of candles 
amounted to about $60.5 million in 2001. The apparent U.S. consumption 
of candles in 2000 (domestic shipments plus imports, minus exports) was 
about $2.0 billion.
    Retail prices of candles range from about 10 cents for a small 
tealight candle up to $75.00 for large columnar candles.
    There are limited data available concerning use of candles in 
homes. According to the NCA, candles are used in 70 percent of U.S. 
households. They are burned one to three times a week by the majority 
of candle consumers. Half of the consumers burn one or two candles at a 
time.

3. Candlewick Information

    There are three general types of candlewicks. Flat braided wicks, 
used in taper candles, make up about 50 percent of U.S. wick 
production. Square wicks, representing less than 10 percent of U.S. 
production, are used in production of beeswax candles and candles that 
develop small wax pools when burning. Cored wicks, which account for 
about 40 percent of wicks used in candles, are rigid and have a central 
core made of cotton, paper, hemp, metal, or polypropylene, surrounded 
by wicking material made of paper or fiber. The cores provide rigidity 
to wicks in candles that produce deep pools of molten wax, and are 
frequently used in votives, pillars, tealights, and other container 
candles.
    CPSC staff identified three domestic producers of candlewicks. The 
leading producer accounts for the majority of wicks used by the U.S. 
candle industry. In addition, there may be several small specialty 
producers of wicks.
    Candlewick manufacturers sell their wicks to wholesalers (candle 
material suppliers) or large candle manufacturers. Some wholesale wick 
suppliers repackage wicks supplied by large producers. The CPSC staff 
has identified 55 wholesale suppliers of candle making materials. Small 
candle producers usually purchase wick material from wholesale firms.
    Small quantities of candlewicks may be purchased by consumers at 
craft stores. They may be purchased in large quantities from wholesale 
firms or direct from manufacturers. Wicks are available on reels or 
precut to desired lengths. Prices vary depending upon how the wick is 
supplied and the quantities ordered. For example, based on one 
manufacturer's list prices, pre-waxed wicks on reels were 12 cents per 
yard and pre-waxed, pre-cut, two-inch wicks were 37 cents per yard. For 
this manufacturer, price did not depend on wick type.
    No specific information is available for domestic shipments or 
sales of candlewicks. However, based on information provided by the 
leading domestic candlewick manufacturer in its comments on the NPR, 
the CPSC staff estimates that total domestic sales of candlewicks could 
be about four to five million dollars annually. Data on international 
trade in wicks do not distinguish candlewicks from other types of wicks 
(e.g., wicks for stoves, lighters, and lamps). Still, imports of all 
types of wicks, including candlewicks, were about $4.1 million in 2001.
    Prior to the granting of the petition, candlewicks with some levels 
of detectable lead were found in the marketplace. In a non-statistical 
survey of candles for sale in the Washington, DC area in 1999, the 
petitioners found that about 30 percent of candles for sale had metal-
cored wicks, and about 10 percent of these (or three percent of all 
candles sampled) had detectable levels (i.e., at least trace levels) of 
lead in the wick.
    According to the NCA, use of lead cored wicks among U.S. 
manufacturers is negligible. Practically all metal-cored wicks 
currently produced in the U.S. are made of zinc. According to the NCA, 
zinc-cored wicks account for about 15 to 20 percent of U.S. production. 
Zinc-cored wicks have trace amounts of lead, about 0.01 percent, 
substantially less than the lead limit in the standard finalized today.

D. 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 CPSC staff briefing packages on Petition No. HP 00-3. 
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 [mu]g of lead per hour during candle 
burning. Thus, the Commission finds 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.

E. International Activities

    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.\3\ Officials in Australia and New 
Zealand instituted provisional bans on candles with wicks containing 
any amount of lead as early as 1999.\4\ Australia recently announced a 
permanent ban on sales of candles with wicks containing more than 0.06 
percent lead.\5\
---------------------------------------------------------------------------

    \3\ Health Canada Advisory 2001-02, January 2001.
    \4\ 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.
    \5\ Press Release No. 057, Senator Ian Campbell, Parliamentary 
Secretary to the Treasury, Commonwealth of Australia, November 1, 
2002.
---------------------------------------------------------------------------

    Denmark issued a 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 100 mg/kg 
(0.01 percent) of the homogeneous components.
---------------------------------------------------------------------------

    \6\ Statutory Order No. 1012 of November 13, 2000, on 
Prohibition of Import and Marketing of Products Containing Lead, 
Ministry of Environment and Energy, Danish Environmental Protection 
Agency.
---------------------------------------------------------------------------

F. Statutory Requirements

    This proceeding is conducted under provisions of the FHSA. 15 
U.S.C. 1261-1278. It involves two actions. First, pursuant to section 
3(a) of the FHSA, the Commission is declaring that metal-cored 
candlewicks containing more than 0.06 percent lead by weight of the 
metal

[[Page 19144]]

and candles with such wicks are hazardous substances. 16 CFR 
1500.12(a)(2). Second, pursuant to section 2(q)(1)(B) of the FHSA, the 
Commission is banning such wicks and candles with such wicks. 16 CFR 
1500.17(a)(13).
    A proceeding to declare a substance to be 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).
    The Commission is declaring that metal-cored candlewicks 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). The basis for this declaration 
is stated in section D. of this preamble, The Risk of Illness.
    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 also 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 CPSC Human Factors staff analysis on the issue of precautionary 
labeling of individual candles concludes that labeling is not an 
acceptable strategy for protecting vulnerable populations from lead 
poisoning that may be caused by burning candles with lead-cored 
wicks.\7\
---------------------------------------------------------------------------

    \7\ See footnote 2 for sources for the CPSC staff analyses 
related to this rulemaking.
---------------------------------------------------------------------------

    That analysis shows that since lead is emitted in unpredictable 
amounts from a candle with a metal-cored wick containing more than 0.06 
percent lead in the metal 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 such wicks. No 
label or subsequent action by the consumer would prevent the release of 
lead into the air if the candle were used as intended. The Commission 
therefore finds that, notwithstanding the precautionary labeling 
required by the FHSA, metal-cored candlewicks containing more than 0.06 
percent lead in the metal and candles with such wicks present a hazard 
such that keeping them out of interstate commerce is the only adequate 
means to protect the public health and safety.
    In addition to today's final rule banning these wicks and candles, 
the FHSA requires that the Commission publish 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 must also find 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 govern this 
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 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.

G. Response to Comments on the NPR

    Six comments were received in response to the NPR. All six comments 
were in favor of a ban on lead-cored wicks. One commenter expressed 
interest in allowing the use of lead-cored candlewicks in certain 
circumstances.
    One wick manufacturer (Atkins and Pearce) and two industry groups 
(Consumer Specialty Products Association, National Candle Association) 
provided comments. One commenter represented a non-profit information 
and advocacy group in Australia (Global Lead Advice and Support 
Service). Two commenters were individual consumers or interested 
parties.

1. Federal Regulation

    Comments: All six commenters support the concept of regulating the 
use of lead in metal-cored candlewicks, although there was disagreement 
about the scope of the proposed regulation, and the proposed 
requirements for testing, certifying, and tracking metal-cored wicks.
    Response: The Commission acknowledges the interest among consumers, 
industry, and advocacy groups in the elimination of candlewicks as a 
source of lead exposure. Responses to specific questions and comments 
about the proposed rule are set forth below.

2. Proposed Record-Keeping Requirements

    Comments: The rule as proposed included requirements that shipping 
cartons of metal-cored candlewicks and shipping cartons of candles with 
such wicks be labeled as complying with the ban and with a lot number 
or other designation, and that wick and candle manufacturers, 
importers, and distributors maintain records documenting compliance 
with the ban for each lot. Representatives from industry expressed 
concern about the costs and labor that would be involved in the 
tracking of metal-cored wicks used in specific candles, and the 
maintenance of records.
    These commenters provided some information about the candle-making 
process to illustrate potential difficulties with the proposed 
requirements. For example, the commenters described machines that 
rapidly produce many candles at once, simultaneously drawing candlewick 
from several different spools. Consequently, a batch of finished 
candles could contain wicks from different lots or sources. Further, 
these candles with different wicks would be indistinguishable and would 
be packaged together at the end of production. Thus, a single shipping 
carton could contain identical candles with different lots of metal-
cored candlewicks. The commenters believe it would be labor intensive 
and costly to change the current method of production so that 
individual lots of

[[Page 19145]]

wicks could be separated and tracked. While not providing alternative 
estimates of costs, the commenters indicated that the staff may have 
underestimated the costs of the labeling and record-keeping 
requirements.
    Response: On the basis of comments received and the CPSC staff's 
further analysis of the complex manufacturing processes described by 
the commenters and the limited benefits expected, the final rule issued 
today does not require record-keeping and tracking.
    Comment: One commenter, a U.S. wick manufacturer, suggested that 
tracking could be done in ways other than labeling shipping cartons 
with a lot number or other identifier. For example, if the wicks in 
specific lots, made with specific lots of metal-core material (e.g., 
zinc wire), could be visually distinguished from each other, 
manufacturers could track candlewick lots without changing current 
manufacturing processes. One way to distinguish wick lots would be to 
incorporate unique colors and patterns into the wick braid. Thus, 
inspecting the wicks in candles from a specified manufacturer would 
provide visual information about the wick lot. Multiple wick lots could 
be used at the same time in candle production, and multiple wick lots 
could end up in the same shipping carton, without losing the ability to 
obtain records for specific candles or track specific lots of metal-
cored wicks. However, additional information provided by this commenter 
indicated that the use of color-coded tracer threads in the candlewick 
could result in increased costs associated with testing the performance 
of the new candlewicks before they could be used in candle production.
    Response: The final rule issued today does not require the record-
keeping and tracking proposed in the NPR.

3. Effective Date

    Comment: One commenter stated that non-complying products should 
not benefit from an extended sell-through period.
    Response: The Commission has no reason to believe that 
manufacturers, importers, or retailers have, or will, warehouse or 
stockpile candles made prior to the effective date that would not 
conform to the rule. Similarly, the Commission has no information that 
suggests that manufacturers, importers, or retailers will stockpile 
non-complying candlewicks for the purposes of producing candles between 
issuance of the final rule and the effective date. Moreover, non-
complying candlewick inventory would not be usable after the effective 
date. The 180-day effective date provides time for manufacturers, 
distributors, and importers to make any necessary changes to bring 
their products and shipping containers into compliance with the 
regulation.

4. Lead-Cored Candlewicks Are Superior for Some Uses

    Comment: A commenter stated that candles with lead-cored wicks 
performed better than candles with other kinds of wicks in a specific 
application (camping lanterns), and suggested that an exemption be made 
to allow specific uses of lead-cored candlewicks in candles.
    Response: Additional information provided by this commenter 
indicates that the candles in question do not actually contain lead-
cored wicks.

5. All Metals Should Be Banned for Use in Candlewicks

    Comment: One commenter, representing an information and advocacy 
group in Australia, suggested that all metal-cored wicks should be 
banned for use in candles to avoid any confusion about whether the 
metal contains unacceptable levels of lead.
    Response: As discussed in the CPSC staff briefing memoranda, 
laboratory test data show 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. Therefore, there 
is no basis for declaring all metal-cored candlewicks and candles with 
such wicks to be hazardous substances.

H. Alternatives to the Ban

1. No Action

    If the Commission took no action, lead-cored candlewicks 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 wicks, 
imports may continue to be a source of lead in the absence of a 
mandatory standard. Under a 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 candlewicks was formed under the ASTM 
F15.45 Candle Products Subcommittee to develop a consensus standard to 
address the lead content of candlewicks. 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, Voices of Safety 
International (VOSI) proffered a voluntary standard for lead in 
candlewicks. CPSC technical staff reviewed the standard and noted a 
number of difficulties. Although the standard stated that a maximum of 
0.01 percent lead is required to protect consumer health, no technical 
or health basis for this level was provided. The CPSC staff maintains 
that the 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 candlewicks. 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. 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 offered no information that its members include 
candle or wick manufacturers. Nor has it provided any evidence that 
there would be substantial compliance with the voluntary standard.

[[Page 19146]]

    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.

3. Precautionary Labeling

    As discussed above in Section F. of this preamble, Statutory 
Requirements, the CPSC Human Factors staff analysis on this issue 
demonstrates 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.

I. Regulatory Analysis

1. FHSA Requirement

    The Commission is issuing 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(i) of the FHSA requires that the 
Commission prepare a final regulatory analysis for this action. 15 
U.S.C. 1262(i). The following discussion addresses this requirement.

2. Introduction

    The Commission is 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. In April 2002, the Commission issued proposed rules that would 
declare such wicks and candles with such wicks to be hazardous 
substances and would ban them. 67 FR 20062.

3. Required Content of the Regulatory Analysis

    To issue the ban rule under the FHSA, the Commission must also 
publish a final regulatory analysis 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(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 Hazardous Substance Ban \8\
---------------------------------------------------------------------------

    \8\ The following discussion of costs and benefits is extracted 
from Memorandum from Mary F. Donaldson, CPSC Directorate for 
Economic Analysis to Kristina Hatlelid, CPSC Directorate for Health 
Sciences, ``Final Regulatory Analysis of a Proposed Ban of Lead in 
Candlewicks,'' March 10, 2003. See footnote 2 for information on the 
availability of this and other related documents for this 
rulemaking.
---------------------------------------------------------------------------

(a) Benefits
    While the benefits to consumers of eliminating lead-cored 
candlewicks as a source of lead exposure are not quantifiable, they are 
likely to be small since few lead-cored candlewicks are now produced 
and/or sold in the U.S. The likely benefits are dependent on individual 
circumstances of candle use. Laboratory studies indicate that under 
certain conditions of use exposure to airborne lead from burning 
candles with lead-cored wicks presents a risk of lead poisoning. 
Therefore, a ban may result in positive health benefits in individual 
cases.
    In the mid-1970s, the Commission chose to defer to the industry's 
voluntary agreement to eliminate lead from candlewicks. Since this 
agreement did not prevent companies from returning to the use of lead-
cored wicks in the 1980s and 1990s, a ban on the use of lead in 
candlewicks will help ensure that lead will not be used in candlewicks 
in the future.
(b) 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 costs of substitutes for 
lead-cored wicks are not higher than costs of wicks made with lead.
    There may be costs associated with labeling and ensuring 
conformance. Shipping carton labeling may be done by direct printing 
onto the carton or by affixing a pre-printed label, such as a sticker. 
On a per carton basis, direct printing is expected to be less costly 
than the use of a sticker. Labeling machines may cost as much as 
$15,000 and individual labels may cost five to 10 cents each. Assuming 
that 15-20 percent of all candles produced would be affected, and that 
each shipping carton holds 144 candles, valued at one dollar each, 
perhaps two to three million shipping cartons would require labeling 
annually. If labels cost five to 10 cents each, then annual costs would 
be about $100,000 to $300,000. The costs to candlewick manufacturers to 
label shipments of metal-cored candlewicks, expected to be 
substantially less than that of candles, are estimated to be about $80 
to $320 per year.
    Consistent with the Commission's lead in consumer products guidance 
policy at 16 CFR 1500.230, domestic producers, distributors, private 
labelers, importers, and retailers of metal-cored candlewicks and 
candles with such wicks may wish to test products to ensure compliance 
with the regulation. Alternatively, firms may wish to obtain assurances 
from suppliers that the lead content of the metal does not exceed 0.06 
percent by weight. This should be relatively straightforward because 
candlewick manufacturers generally receive chemical analyses from the 
suppliers of the metal used in their candlewick production.
    Finally, there may be costs associated with inventories of non-
complying candlewicks held by manufacturers. The rule would apply to 
candlewicks or candles manufactured on and after the rule's effective 
date. Therefore, non-complying candlewicks would have to be scrapped 
under the regulation since they would no longer be usable in candle 
manufacturing on and after the effective date. It is not anticipated, 
however, that a large amount of candlewick inventory would be affected.
    In summary, while the benefits of a ban of lead in candlewicks are 
likely to be small, the costs of the ban to the industry are small, and 
thus bear a reasonable relationship to the benefits. The action will 
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, recordkeeping for wick/candle 
shipments and deferral to a voluntary standard. See discussions above 
at section G., Response to Comments on the NPR, and section H., 
Alternatives to Proposed Ban.

J. Paperwork Reduction Act

    The ban regulation as proposed would have required manufacturers 
and importers of metal-cored candlewicks and candles with such wicks to 
perform testing or obtain records of testing, maintain records, and 
label shipping

[[Page 19147]]

containers for metal-cored candlewicks and candles with such wicks that 
they produce or import. For this reason, the proposed rule contained 
``collection of information requirements,'' and would have been subject 
to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3520.
    As noted above in section G., Response to Comments, the Commission 
has elected to delete these recordkeeping requirements from the final 
rule issued today. Accordingly, the rule as finalized is not subject to 
the PRA.

K. Regulatory Flexibility Act Certification

    When an agency issues a final rule such as the ban on lead-cored 
candlewicks and candles with such wicks, 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 a final regulatory flexibility analysis 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. That assessment 
reported that the costs to consumers and candlewick and candle 
manufacturers were likely to be small.
    After analyzing the comments received in response to the NPR, the 
CPSC staff has concluded that the incremental cost of the rules issued 
today is likely to be small. Accordingly, it is unlikely that the rules 
will have a substantial effect on a significant number of small 
businesses.
    Based on the foregoing assessment, the Commission certifies that 
the rules issued today 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 
will not have a significant adverse impact on a substantial number of 
small businesses or other small entities.

L. 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 assessed the 
possible environmental effects associated with the hazardous substance 
declaration and ban for metal-cored candlewicks 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. Assessment of the impact of the rules issued today 
indicates that they will have no significant effects on the 
environment. Thus, the Commission concludes that no environmental 
assessment or environmental impact statement is required in this 
proceeding.

M. Effective Date

    The rule issued today provides an effective date 180 days after 
publication in the Federal Register. The time before that date may be 
used for depletion of any existing stocks of candlewick material and 
candles subject to the ban. The ban then applies to any metal-cored 
candlewick 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.

N. Executive Order 12988

    As provided for in Executive Order 12988 (February 5, 1996), the 
CPSC states the preemptive effect of these 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 rule banning metal-cored 
candlewicks containing more than 0.06 percent lead by weight of the 
metal and candles with such wicks preempts non-identical state or local 
requirements applicable to such wicks and candles designed to protect 
against the same risk of injury.

O. Conclusion

    For the reasons stated in this preamble, the Commission finds that 
metal-cored candlewicks 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, Reporting and 
recordkeeping.

0
For the reasons stated in the preamble, the Commission amends title 16 
of the Code of Federal Regulation to read as follows:

PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND 
ENFORCEMENT REGULATIONS

0
1. The authority for part 1500 continues to read as follows:


    Authority: 15 U.S.C. 1261-1278.


0
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 candlewicks 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.
* * * * *

0
3. In Sec.  1500.17, add new paragraphs (a)(13) and (b) to read as 
follows:


Sec.  1500.17  Banned hazardous substances.

    (a) * * *

[[Page 19148]]

    (13)(i) Candles made with metal-cored wicks. Candles manufactured 
or imported on or after October 15, 2003, made with metal-cored 
candlewicks, unless:
    (A) The metal core of each candlewick has a lead content 
(calculated as the metal) of not more than 0.06 percent of the total 
weight of the metal core; and
    (B) Each outer container or wrapper in which candles subject to 
paragraph (a)(13)(i)(A) of this section are shipped, including each 
outer container or wrapper in which such candles are distributed to a 
retail outlet, is labeled ``Conforms to 16 CFR 1500.17(a)(13).'' For 
purposes of this paragraph (B), 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.
    (ii) Metal-cored candlewicks. Metal-cored candlewicks manufactured 
or imported on or after October 15, 2003, unless:
    (A) The metal core of each candlewick has a lead content 
(calculated as the metal) of not more than 0.06 percent of the total 
weight of the metal core; and
    (B) Each outer container or wrapper in which candlewicks subject to 
paragraph (a)(13)(ii)(A) of this section is shipped, including each 
outer container or wrapper of a shipment distributed to a retail 
outlet, is labeled ``Conforms to 16 CFR 1500.17(a)(13).'' For purposes 
of this paragraph (B), the term ``outer container or wrapper'' does not 
include the immediate container in which candlewick(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 candlewick(s) is/are 
shipped to a retailer.
    (iii) Findings--(A) General. 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 Commission must make certain 
findings and include them in the regulation. These findings are 
discussed in paragraphs (a)(13)(iii)(B) through (D) of this section.
    (B) Voluntary Standard. 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 candlewicks 
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 candlewick 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 $100,000 to $300,000. 
On a percentage basis these costs represent only 0.005 to 0.015 percent 
of the overall value of candle shipments in 2000, which was 
approximately $2 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; recordkeeping for shipments of wicks containing 0.06 percent or 
less lead by weight of the metal and of candles with such wicks; and 
relying on the voluntary standard. Neither no action, nor labeling, nor 
reliance on the voluntary standard would adequately reduce the risk of 
illness. Recordkeeping for shipments of wicks and of candles was not 
the least burdensome requirement that would prevent or adequately 
reduce the risk of illness. Therefore the Commission finds that a ban 
on candlewicks 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.
    (b) [Reserved].

    Dated: April 9, 2003.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.

Appendix--

List of Relevant Documents

(This Appendix Will Not Appear in the Code of Federal Regulations)

    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 Candlewicks,'' 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 Candlewicks,'' 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.
6. ``Briefing Package for Ban of Candles with Lead-containing Wicks 
and Wicks for Candle-making that Contain Lead--Final Rule,'' 
Kristina M. Hatlelid, Ph.D., M.P.H., Toxicologist, Directorate for 
Health Sciences, March 27, 2003.

[FR Doc. 03-9255 Filed 4-17-03; 8:45 am]
BILLING CODE 6355-01-P