[Federal Register: April 18, 2003 (Volume 68, Number 75)]
[Rules and Regulations]
[Page 19142-19148]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap03-3]
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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.
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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).
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\1\ The Commissioners voted 3-0 to issue these final rules.
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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\
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\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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.cpsc.gov and from
the CPSC office of the Secretary, Room 502, 4330 East West Highway,
Bethesda, Maryland, 20814, (301) 504-7923.
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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\
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\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.
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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.
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\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.
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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\
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\7\ See footnote 2 for sources for the CPSC staff analyses
related to this rulemaking.
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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\
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\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.
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(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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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