83 FR 12254 - Labeling of Certain Household Products Containing Methylene Chloride; Supplemental Guidance

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 83, Issue 55 (March 21, 2018)

The Halogenated Solvents Industry Alliance petitioned the Consumer Product Safety Commission to amend its 1987 policy statement regarding the labeling of certain products containing methylene chloride to address acute hazards from inhaling methylene chloride vapors in addition to the chronic hazards addressed in the policy statement. In this document, the Commission updates the 1987 policy statement to provide guidance regarding the labeling to warn of acute hazards associated with paint strippers containing methylene chloride.

[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Rules and Regulations]
[Pages 12254-12259]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05580]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Chapter II

[Docket No. CPSC-2016-2019]


Labeling of Certain Household Products Containing Methylene 
Chloride; Supplemental Guidance

AGENCY: Consumer Product Safety Commission.

ACTION: Guidance.

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SUMMARY: The Halogenated Solvents Industry Alliance petitioned the 
Consumer Product Safety Commission to amend its 1987 policy statement 
regarding the labeling of certain products containing methylene 
chloride to address acute hazards from inhaling methylene chloride 
vapors in addition to the chronic hazards addressed in the policy 
statement. In this document, the Commission updates the 1987 policy 
statement to provide guidance regarding the labeling to warn of acute 
hazards associated with paint strippers containing methylene chloride.

DATES: This guidance document becomes applicable on March 21, 2018.

FOR FURTHER INFORMATION CONTACT: Carol Afflerbach, Office of Compliance 
and Field Operations, U.S. Consumer Product Safety Commission; 4330 
East-West Highway, Bethesda, MD 20814; email: [email protected]; 
telephone: (301) 504-7529.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1987, the U.S. Consumer Product Safety Commission (CPSC or 
Commission) issued a Statement of Interpretation and Enforcement Policy 
regarding the labeling of certain household products containing 
methylene chloride (1987 Statement), 52 FR 34698 (Sept. 14, 1987). The 
1987 Statement noted that the Commission considers certain household 
products containing methylene chloride (DCM) to be ``hazardous 
substances'' under the FHSA and may pose a risk of carcinogenicity. The 
1987 Statement identified several categories of products that contained 
methylene chloride that could expose consumers to significant amounts 
of methylene chloride vapor, and were thus hazardous substances. Paint 
strippers were one of these product categories. The 1987 Statement 
advised manufacturers of the FHSA's labeling requirements and provided 
guidance for labeling those products, including paint strippers, to 
warn of the cancer risk from inhaling methylene chloride vapor.
    On July 7, 2016, the Halogenated Solvents Industry Alliance (HSIA 
or petitioner) petitioned the CPSC to amend its 1987 Statement to 
recognize the acute hazard posed by using household products containing 
DCM in enclosed spaces with inadequate ventilation. The petitioner 
stated that using household products containing DCM in bathrooms, or 
other enclosed spaces, with inadequate ventilation can be dangerous. 
When consumers use methylene chloride to strip coatings from bathtubs, 
they often spray or pour a bathtub stripping product into the basin of 
the bathtub and then brush the product onto the tub surface. Many of 
these stripping products contain substantial amounts of methylene 
chloride. According to the petitioner, methylene chloride is a volatile 
organic compound that will evaporate quickly when sprayed, brushed, or 
poured, so that its vapor can quickly build up in small spaces. The 
petitioner stated that DCM has a high vapor pressure, which causes 
vapors to collect in the bottom of a bathtub and in a consumer's 
breathing zone when working in a bathtub. This situation can create 
dangerously high concentrations of DCM, and in some cases, replace the 
breathable air. The petitioner asked the Commission to expand the 
cautionary labeling guidance so that it also warns of the threat of 
asphyxiation if DCM-based paint strippers are used in an enclosed 
space.
    CPSC staff prepared a briefing package in response to the petition 
and submitted the package to the Commission on May 26, 2017. On June 2, 
2017, the Commission voted unanimously (5-0) to grant the petition (HP 
16-1) and directed CPSC staff to draft a policy statement that 
addresses labeling for acute hazards from inhaling methylene chloride 
vapors from paint strippers.

II. EPA Rulemaking

    The EPA has initiated rulemaking under section 6(a) of the Toxic 
Substances Control Act (TSCA) to address risks posed by DCM when used 
in paint and coating removal products. Specifically, EPA has issued a 
proposed rule that provides an assessment of the health hazards posed 
by DCM and that proposes to determine that DCM in these products 
presents an unreasonable risk of injury to health. Based on this 
determination, and after considering regulatory alternatives, EPA 
proposed to prohibit the manufacture (including import), processing, 
and distribution in commerce of DCM for all consumer and most 
commercial paint removal products, and to prohibit commercial use. 82 
FR 7464 (Jan. 19, 2017). EPA's rulemaking would address both consumer 
and worker exposures to DCM used for paint and coating removal. While 
developing its rulemaking, EPA consulted with CPSC staff. Under EPA's 
rulemaking (if finalized as proposed), paint and coating removal 
products containing DCM would no longer be on the market for consumers 
or commercial workers, except in limited circumstances. To date, EPA 
has not finalized its rulemaking. Accordingly,

[[Page 12255]]

the Commission believes that updating CPSC's 1987 Statement would 
provide more immediate guidance and clarity to industry and consumers 
regarding the acute hazards associated with using DCM-containing paint 
strippers while those products remain on the market. By updating the 
1987 Statement, we do not suggest that labeling will address all 
hazards EPA identified in its proposed rulemaking.

III. Federal Hazardous Substances Act (FHSA) Labeling Requirements

    The CPSC regulates hazardous household substances under the FHSA, 
15 U.S.C. 1261-1276. Section 2(p)(1) of the FHSA, 15 U.S.C. 1261(p)(1), 
requires that a hazardous substance bear certain cautionary statements 
on its label in a prominent and conspicuous manner so that consumers 
can safely use and store the product in and around the household. A 
product is a ``hazardous substance'' under the FHSA if the substance or 
a mixture of substances is toxic, corrosive, an irritant, a strong 
sensitizer, is flammable or combustible, or generates pressure through 
decomposition, heat, or other means, and if the substance or mixture of 
substances may cause substantial personal injury or substantial illness 
during customary or reasonably foreseeable handling or use, including 
reasonably foreseeable ingestion by children.
    The FHSA defines ``toxic'' as ``any substance . . . which has the 
capacity to produce personal injury or illness to man through 
ingestion, inhalation, or absorption through any body surface.'' 15 
U.S.C. 1261(g). The Commission has issued a regulation at 16 CFR 
1500.3(c), which supplements the statutory definition of ``toxic'' 
based on the outcome of any of the approved test methods described in 
CPSC's animal testing policy set forth at 16 CFR 1500.232. This 
definition also includes chronic toxicity and states that a substance 
is toxic if it presents a chronic hazard, if it is a known or probable 
human carcinogen, neurotoxin, or developmental or reproductive 
toxicant.
    Under the FHSA, an article that is intended, or packaged in a form 
suitable for household use and meets the definition of ``hazardous 
substance'' is a ``misbranded hazardous substance'' unless its 
packaging or labeling warns of the hazard in accordance with the 
requirements of section 2(p). 15 U.S.C. 1261(p). Thus, cautionary 
statements are required for household substances meeting the definition 
of ``hazardous substance'' under the FHSA, whether the hazard is acute 
or chronic.

IV. Staff's Review of Toxicity and Incident Data

A. Acute Toxicity Data

    CPSC staff reviewed relevant data to evaluate the acute toxicity 
risk to consumers from using DCM-containing products in residential 
settings. Staff's petition briefing package provided detailed 
information about staff's review. (https://www.cpsc.gov/s3fs-public/RCA%20-%20Petition%20HP%2016-1%20Labeling%20of%20Household%20Products%20Containing%20Methylene%20Chloride%20082316.pdf).
    DCM is a highly volatile, colorless, organic substance used as a 
solvent in a variety of consumer and commercial products, including 
paint strippers, adhesives and adhesive removers, spray paint, spray 
shoe polish, and cleaners. DCM's high volatility makes inhalation its 
primary route of exposure.\1\ The acute toxicity risks for consumers 
using DCM-based products in residential settings range from upper 
respiratory, ocular and dermal irritation, to severe effects, such as 
respiratory suppression, loss of consciousness, and death.\2\ Both 
consumer and worker deaths have been attributed to scenarios where the 
individuals were working alone in an enclosed and/or poorly ventilated 
space (e.g., bathrooms, basements, sheds) without respiratory 
protection. The toxic effects are from DCM as well as carbon monoxide 
(CO), which is a metabolite of DCM. Bystanders are also at risk of 
acute health effects while in the home when paint strippers and similar 
DCM-based products are being applied.\3\
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    \1\ ATSDR. 2000a. TOXICOLOGICAL PROFILE FOR METHYLENE CHLORIDE. 
3.13; CDC. 2012. Fatal Exposure to Methylene Chloride Among Bathtub 
Refinishers--United States, 2000-2011. MMWR. 61:4; EPA. 2014. TSCA 
Work Plan Chemical Risk Assessment Methylene Chloride: Paint 
Stripping Use. EPA Document #740-R1-4003. August 2014:279.
    \2\ EPA. 2009. INTERIM ACUTE EXPOSURE GUIDELINE LEVELS (AEGLs) 
for METHYLENE CHLORIDE. Interim 1: 12/2008:110.
    \3\ EPA, 2014.
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    The primary route of exposure for DCM is inhalation; however, DCM 
can readily be absorbed through dermal (skin) contact as well. To 
protect against skin absorption, butyl rubber or polyvinyl alcohol 
gloves must be worn because latex gloves will not protect against skin 
absorption.\4\ DCM should only be used in a well-ventilated area. In 
2013, CPSC staff developed a pamphlet concerning paint strippers which 
provides guidance to consumers on ventilation practices when they use 
DCM-containing paint strippers. The CPSC pamphlet recommends that 
paint-stripping work be done professionally if the work area has low-
ventilation conditions.\5\ The U.S. Department of Labor's Occupational 
Safety and Health Administration (OSHA) indicates in its hazard alerts 
that bathroom fans and/or open windows do not provide adequate 
ventilation when using these paint strippers in an enclosed space, such 
as a bathroom.\6\ Inhalation exposure to as little as six ounces is 
sufficient to cause death.\7\ While working with DCM, consumers and 
workers must use respiratory protective equipment, such as tight-
fitting, full-face, self-contained supplied-air respirators or gas 
masks with vapor canisters, to reduce exposure.\8\ Because DCM vapors 
are heavier than air, they can remain in the work area and become very 
hazardous to users. For example, if using a DCM-containing paint 
stripper to renovate a bathtub, inhalation exposure could occur due to 
the vapors remaining in the bathtub after application.\9\ This exposure 
may lead to death if proper precautions, such as protective equipment 
and ventilation, are not used.\10\ To obtain adequate ventilation, use 
a qualified occupational health and safety specialist to assist in 
designing and installing local exhaust ventilation to effectively 
control vapors to below applicable personal exposure levels.
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    \4\ CDC, 2012. CPSC. 1987b. Statement of Policy for Methylene 
Chloride. FindLaw; IRIS, 2011.
    \5\ CPSC, 2013. What You Should Know About Using Paint 
Strippers. 423.
    \6\ OSHA, 2013. Hazard Alert. ``Methylene Chloride Hazards for 
Bathtub Refinishers''; OSHA, 2016. FATAL Facts, Ho. 13-2016, 
``Lethal Exposure to Methylene Chloride during Bathtub 
Refinishing.''
    \7\ OSHA, 2013.
    \8\ OSHA DCM regulations, 29 CFR 1910.1052, require employers to 
supply employees with respirators, and require employees to use the 
respirator when exposures are likely to exceed the regulatory 
limits.
    \9\ CDC, 2012.
    \10\ ATSDR, 2000b; CDC, 2012; EPA, 2014.
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B. Incident Data

    Staff searched CPSC databases for information about incidents 
reported to CPSC associated with DCM-based paint strippers and other 
household products containing DCM. Staff also searched the Consumer 
Product Safety Risk Management System (CPSRMS) and the National 
Electronic Injury Surveillance System (NEISS).
    Between January 1, 2000 and November 30, 2017, there were 30 
incidents associated with household products containing or likely 
containing DCM reported to CPSC by December 5, 2017. The majority of 
the incidents (28) were associated with paint strippers; one incident 
was associated with an unspecified solvent; and one incident

[[Page 12256]]

was associated with a sealant. The incident reports mentioned fumes, 
inhalations, skin and lung irritation, leaking, and spilling. Based on 
information provided by consumers, 17 incidents were associated with 
DCM-based household products (the incidents either mentioned DCM or 
provided the product SKU# that allowed CPSC staff to identify a DCM-
based product). Thirteen incident reports named paint strippers 
containing DCM.\11\ CPSC staff determined that these incidents are 
likely associated with DCM-based paint strippers. Among the 30 reported 
incidents, there were 6 fatalities, 1 hospital admission, 1 emergency 
department visit, 15 injuries/adverse health problems, 4 non-injury 
incidents, and 3 incidents without enough information to determine 
whether an injury occurred.
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    \11\ California Department of Public Health, ``Guide to choosing 
paint stripping products: Safety considerations'' http://www.cdph.ca.gov/programs/hesis/Documents/Paint-Removal-Methods.pdf.
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    CPSC staff is aware of six deaths involving DCM-based products \12\ 
that occurred between January 1, 2000, and November 30, 2017. The 
victims were males between 45 and 80 years old. In most of the cases (5 
deaths), CPSC staff was not able determine whether the incidents were 
associated with a consumer or a worker. These fatal incidents are 
described in more detail in the petition briefing package. The 
Commission has since learned of an incident that occurred in October 
2017, in Charleston, SC, involving a paint stripper, which resulted in 
death from acute DCM and methanol toxicity. This case is still under 
investigation to determine whether it is a consumer or worker incident.
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    \12\ These DCM-based products included four paint removers, one 
unspecified solvent, and one sealer.
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    In 2002, a 64-year-old male fell into a tank of paint stripper at 
work. The paint stripper contained DCM. The cause of death was recorded 
as a cardiac arrest and respiratory toxicity. Although this case is a 
work-related incident, and therefore, not within CPSC's jurisdiction, 
the case, nonetheless, indicates the potential hazard of the product. 
Another incident that occurred in 2002 involved a 52-year-old male. He 
died as a consequence of inhaling fumes from a DCM-based solvent in a 
bathroom. In 2007, a 45-year-old male died after inhaling paint remover 
fumes during a bathroom renovation. The cause of death was determined 
to be asphyxia due to inhaling DCM. In 2013, an 80-year-old male died 
after inhaling DCM fumes while using a paint stripper in a shed. Also 
reported in 2013, a 50-year-old male died after inhaling DCM fumes 
while stripping an apartment's bathroom. In 2016, a 48-year-old male 
was sealing bathroom shower tiles with a DCM-based sealer in a 
bathroom. He died as a consequence of asphyxiation from exposure to 
toxic DCM fumes.

V. Labeling Paint Strippers Containing Methylene Chloride

    This section contains guidance on minimum recommendations for how 
the acute and chronic health risks of DCM use could be conveyed in the 
Principal Display Panel (PDP) and the back or other panel to 
effectively inform consumers and motivate their safe use of paint 
stripping products containing DCM.
    Currently, there are few suitable alternatives to DCM, and 
protective measures, such as moving products outdoors to apply the 
stripper can be inconvenient. Providing warning information does not 
prevent consumer exposure to hazards, but instead, relies upon 
persuading consumers to alter their behavior in some way to avoid the 
hazard. In addition, warnings research demonstrates that even small 
inconveniences to the consumer can have a substantial negative effect 
on behavioral compliance with a warning.\13\ Therefore, it is 
imperative that warning labels are formatted and contain information so 
that they are likely to be noticed, read, understood, and heeded.
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    \13\ Ayres T.J., Gross M.M., Wood C.T., Horst D.P, Beyer R.R., & 
Robinson J.N. (1989). What is a Warning and When Will it Work? 
Proceedings of the Human Factors Society Annual Meeting, 33. 426-
430; Riley, D.M. (2006). Beliefs, Attitudes, and Motivation. In M.S. 
Wogalter (Ed.), Handbook of Warnings (pp. 289-300). Mahwah, NJ: 
Lawrence Erlbaum Associates.
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A. General Principles of Warning Labels

1. Format of Warning Label
    Research has shown that warning information is more effective when 
it is conspicuous.\14\ Repetition with variation and consistent 
reinforcement can increase the effectiveness of messages.\15\ Strategic 
use of capitalization, bolding, underlining, and other forms of 
highlighting information can steer the consumer's attention to the most 
pertinent information by making it stand out from the surrounding 
text.\16\
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    \14\ Wogalter, M.S., DeJoy, D., & Laughery, K.R. (Eds.). (1999). 
Warnings and risk communication. Philadelphia, PA: Taylor & Francis.
    \15\ Food and Drug Administration. (2011). Communicating risks 
and benefits: An evidence-based user's guide (DHHS). B. Fischhoff, 
N.T. Brewer & J.S.Downs (Eds.).
    \16\ Wogalter, M.S., Conzola, V.C., & Smith-Jackson, T.L. 
(2002). Research-based guidelines for warning design and evaluation. 
Applied Ergonomics, 33, 219-230.
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2. Order of Safety Information
    Experts in the communication of safety information agree that 
associated hazards and symptoms should be mentioned from most-to-least 
severe.\17\ Research indicates that many consumers will only read as 
much of the safety information as they think they have to read and only 
if the rewards meet or exceed the efforts.\18\ If lesser hazards and 
symptoms of overexposure to DCM precede more severe hazards and 
symptoms on the label, then the consumer might stop reading the label 
before reaching the more severe hazards and symptoms. Mentioning 
lethality of vapor inhalation at the start raises the likelihood that 
the consumer is informed of the possibility of death. By highlighting 
the pertinent information and beginning with the risk of death, the 
warning information is more apt to prove to the consumer that the 
warning contains useful information, and is, thereby, more likely to be 
read in its entirety. Furthermore, the Commission believes that if 
lesser symptoms of overexposure were to precede more severe symptoms on 
the warning labels, then consumers may expect lesser symptoms to happen 
before more severe symptoms present, which may not be the case. For 
example, if consumers read that DCM inhalation can cause nausea and 
dizziness, before reading that DCM can cause death, consumers may 
infer, incorrectly, that they will not be killed by the product without 
first exhibiting nausea or dizziness. Presenting effects of 
overexposure from most to least severe, along with stating that 
symptoms may not be noticeable, helps to dispel the false expectation 
that the way the consumer is using the DCM-containing paint stripper is 
safe, or that the consumer can use it in an unsafe manner, until s/he 
notices lesser symptoms of overexposure.
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    \17\ Wogalter et al., 1999.
    \18\ Robinson, 2009; Schriver, 1997.
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3. Warning Label Comprehension
    It is important for warning information not only to be noticed and 
read, but also understood. Warnings should be free of ambiguity to 
better ensure that the intended message is received and not easily 
misinterpreted.\19\ For example, the phrase ``adequate ventilation'' is 
ambiguous and can encourage inappropriate methods of circumvention; 
from ``adequate ventilation'' the consumer may infer that any addition 
of ventilation to the application area, such as opening a window, will 
be sufficient to make the

[[Page 12257]]

product safe for indoor use. Such an inference can lead to overexposure 
to DCM-containing vapors, potentially resulting in death. Similarly, 
unclear wording, such as, ``use in enclosed areas may kill you,'' 
carries the risk of being misread as simply, ``use in enclosed areas,'' 
because the word ``use'' in this context can be read as a verb, such as 
``use this product,'' rather than read as a noun, such as ``use of this 
product,'' and because the consumer may stop reading the statement 
before reaching ``may kill you.''
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    \19\ Wogalter et al., 1999.
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    To increase the likelihood of consumers heeding a warning despite 
inconveniences imposed by necessary precautions, the phrasing of 
warning information should be vivid and relatable.\20\ The Commission 
recommends using the phrase ``can kill you,'' as opposed to wording 
like: ``may cause death.'' These phrases have the same denotation; 
however, the impact on the reader can be different in meaningful ways. 
The Commission believes lethality is more salient with the statement 
``can kill you'' because it is more personalized, directing the hazard 
toward the user, rather than as a possibility for users, in general. 
Evidence suggests that emotional communications, especially those that 
are fear-based, can be used to increase risk perceptions and change 
behaviors; and stronger fear-arousing conditions may lead to greater 
message acceptance.\21\
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    \20\ Murray-Johnson, L., & Witte, K. (2003). Looking toward the 
future: Health message design strategies. In T.L. Thompson, A. 
Dorsey, K.I. Miller, & R. Parrot (Eds.), Handbook of health 
communication (pp.473-495). New York City, NY: Routledge.
    \21\ Food and Drug Administration, 2011.
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4. Effect of Consumer Experience With Product
    Warning information can be formatted in a way that is noticeable, 
more likely to be read, understood, and motivating, and yet remain 
unheeded. Research indicates that consumers who are familiar or 
experienced with a product are less likely to search for and comply 
with warnings.\22\ Paint strippers containing DCM have been around for 
decades, and incident data show that these products are sometimes 
applied indoors, such as in bathrooms, basements, and closets. The 
Commission believes that it is foreseeable that some consumers will 
continue to use these products indoors, despite warnings against using 
them in enclosed areas because of past incident-free experience with 
indoor use of stripping products containing DCM. Therefore, the 
Commission suggests including precautions for indoor use as well. 
However, because providing precautions for indoor use may mislead some 
consumers to believe it is safe to use DCM-based products indoors, the 
Commission recommends that the language and format of the safety 
information clarify that use in enclosed areas is dangerous, even with 
precautions, and should be avoided, if possible. The examples provided 
specify that indoor use is dangerous, and they employ repetition and 
capitalization to reinforce the point that paint-stripping products 
containing DCM should be used outdoors in open air areas.
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    \22\ Wogalter et al., 1999.
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B. Principal Display Panel (PDP) Minimum Labeling Recommendations

    This section provides recommendations for labeling paint stripping 
products that contain methylene chloride. The following minimum 
labeling recommendations for the PDP meet the requirements of the FHSA. 
There are wide variations in the concentrations of methylene chloride 
in paint strippers. The precise labeling used may vary based on DCM 
concentration, anticipated duration of exposure, and other associated 
hazards.
    The labels for all products subject to the FHSA are expected to 
comply with the requirements for prominence, placement, and 
conspicuousness of labeling required by section 2(p)(1) of the FHSA. 
The FHSA provides that required labeling statements may be placed on 
the PDP, or front panel, on the immediate container, and, if 
appropriate, on any other container or wrapper. The appropriate signal 
word (i.e., ``DANGER,'' ``WARNING,'' or ``CAUTION) and the statement of 
principal hazard[s] are required to be on the PDP. The other items of 
required labeling may be placed on some other display panel on the 
container, provided that the front panel contains the statement: ``Read 
carefully other cautions on the [other display] panel,'' or its 
practical equivalent.
     The Commission recommends ``WARNING'' as the signal word 
for the label. Given cases of lethal exposure to DCM in household 
products, the Commission considered the signal word ``DANGER''; 
however, the current DCM toxicity data do not meet the FHSA definition 
of ``highly toxic,'' which is required for use of the the signal word 
``DANGER.''
     When providing affirmative statements of all principal 
hazards, the Commission recommends stating: ``INHALATION OF VAPOR VERY 
HARMFUL,'' followed by: ``VAPOR CAN KILL YOU IN ENCLOSED AREAS.''
Example From 1987 Statement of Cautionary Labeling To Be Included on 
the PDP \23\
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    \23\ Given the previously limited data on the acute toxicity of 
overexposure to DCM, the Commission believed this labeling to meet, 
and in certain respects exceed, the minimum requirements of section 
2(p)(1) of the FHSA.
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    In 1987, the Steering Committee for Methylene Chloride, a group of 
industry and consumer-interest representatives working with Commission 
staff, recommended the following labeling for the PDP for products, 
such as some paint strippers that contain high percentages of DCM:

CAUTION: Vapor Harmful, Read Other Cautions and HEALTH HAZARD 
INFORMATION on Back Panel

    In the 1987 Statement, the Commission presented this labeling for 
the PDP as an example that would meet or exceed the minimum 
requirements of the FHSA.
Updated Example of Cautionary Labeling
    In recognition of updated data on acute health risks of DCM use, 
the Commission recommends replacing the 1987 example of cautionary 
labeling to be included on the PDP with the information and format 
below:

WARNING: INHALATION OF VAPOR VERY HARMFUL VAPOR CAN KILL YOU IN 
ENCLOSED AREAS EYE AND SKIN IRRITANT. Read All Cautions on Back/Side 
Panel.

    The format in the updated PDP example uses capital letters, 
repetition, and personalized language to draw attention to the most 
severe hazard: Death from inhalation of vapor in enclosed areas. The 
repetition of ``vapor'' between the first and second lines aids in 
communicating the source and medium by which the hazard presents 
itself. The inclusion of ``vapor very harmful'' satisfies the 
declaration of both the acute and the chronic hazard. When a chronic 
hazard exists, the additional risk of cancer should be included on the 
back or other panel, as appropriate under the FHSA. The last line 
directs the consumer to the back or other panel, which provides 
detailed precautionary information.

C. Back or Other Panel

1. Back or Other Panel Minimum Labeling Recommendations
    The Commission recommends the following information and formatting 
for the back or other panel of paint stripping products containing DCM.

[[Page 12258]]

These recommendations cover both acute and chronic hazards. Again, the 
statements may vary based on the concentration of DCM, anticipated 
duration of exposure, and other associated hazards.
     The Commission recommends use of ``WARNING'' as the signal 
word for the label.
     The Commission recommends beginning the precautionary 
information by stating, in all capital letters, the lethality of vapor 
inhalation and not to use the product in enclosed areas.
     The FHSA requires disclosure of all principal hazards. The 
Commission recommends disclosing the acute and chronic hazards from 
most-to-least severe. Similarly, when symptoms are mentioned, the 
Commission recommends it would be most effective to state symptoms from 
most-to-least severe.
     Because overexposure to DCM may be sudden and can inhibit 
the user's capability to notice and react to the effects, the 
Commission recommends indicating in all capital letters that symptoms 
may not be noticeable.
     The Commission recommends separating precautionary 
statements by bullet points, if paragraph formatting is used, to aid 
visual distinction between precautions.\24\
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    \24\ See the ``Recommended Language Approved by Ad Hoc Task 
Group, Revision C'' document dated November 10, 2017, published in 
the ``Committee Documents'' section of the Committee F15 ASTM 
website.
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     The Commission believes it will be helpful to provide 
specific examples of spaces in which the product should not be used, 
beginning with bathrooms, basements, and closets because these 
locations are particularly dangerous and have been cited in incident 
data.
     When indicating precautions to be taken, the Commission 
recommends stating in all capital letters that the product should be 
used outdoors in an open-air area.
     The Commission recommends including precautionary 
information for indoor use, accompanied by language stating that indoor 
use is dangerous even when precautions are taken.
     The Commission recommends prohibiting foreseeable 
inappropriate actions, such as use of a dust mask to provide protection 
against vapors.\25\
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    \25\ A dust mask does not provide effective protection against 
overexposure to vapors containing DCM.
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     When providing instructions for first-aid, the Commission 
recommends listing in order of the likelihood of occurrence, the types 
of exposures and placing each exposure route on a separate line to aid 
DCM users in an urgent situation.
2. Example of Updated Safety Information To Be Included on the Back or 
Other Panel
    In recognition of updated data on acute health risks of DCM use, 
the Commission recommends replacing the 1987 example of labeling to be 
included on the back or other panel, with the information and format 
below:

    WARNING Contains Methylene Chloride. INHALATION OF VAPOR CAN 
KILL YOU. DO NOT USE IN ENCLOSED AREAS, such as bathrooms, 
basements, or closets. SYMPTOMS MAY NOT BE NOTICEABLE. [ssquf] Avoid 
contact with eyes or skin, as severe irritation can occur. [ssquf] 
Methylene Chloride may cause cancer. [ssquf] The risk to your health 
depends on the level and duration of exposure. [ssquf] Keep out of 
the reach of children.
    SAFETY DIRECTIONS: [ssquf] USE OUTDOORS IN AN OPEN AIR AREA. It 
is dangerous to use this product indoors. [ssquf] If you must use 
indoors, cross-ventilate work area by opening all windows and doors 
and circulating fresh air through the work area to reduce vapor 
accumulation. [ssquf] Always wear chemical-splash goggles and 
chemical-resistant gloves when handling this product. [ssquf] A dust 
mask does not provide protection against the vapors.
    FIRST-AID:
     INHALATION: First move person to fresh air. If not 
breathing, give artificial respiration. Call 911, or poison control 
center, or emergency room.
     EYE EXPOSURE: Immediately flush affected eye(s) with 
water. Call 911, or poison control center, or emergency room, as 
soon as possible.
     SKIN EXPOSURE: Immediately wash skin with soap and 
water. Avoid spreading material on unaffected skin. Remove 
contaminated clothing and shoes, and thoroughly clean before reuse. 
Contact medical professional for advice.
     IF SWALLOWED: IMMEDIATELY call 911, or poison control 
center, or emergency room. Do NOT induce vomiting, unless directed 
to do so by medical personnel. Never give anything by mouth to an 
unconscious person.

    In the preceding updated back or other panel example, the most 
important safety information is capitalized to attract the consumer's 
attention; i.e., if the consumer only reads the capitalized words, his/
her focus is drawn to the following information: Inhaling the vapor can 
be deadly; the product should not be used in enclosed areas; symptoms 
of overexposure may go unnoticed; and the product should be used 
outdoors. Bullet points are used to aid visual distinctions among 
precautions. The presentation of the hazards from most-to-least severe, 
coupled with the statement that symptoms may go unnoticed, helps to 
dismiss the false expectation that the consumer can wait for noticeable 
symptoms before taking appropriate precautions or escaping from a 
potentially lethal-use scenario. Steps for inhibiting vapor 
accumulation indoors are included in the back or other panel, 
subsequent to reiteration that household products containing DCM should 
be used outdoors and that indoor use is dangerous. The instructions for 
first-aid are adapted from OSHA's Chemical Database.\26\ The 
instructions are listed in order of the likelihood of exposure route 
per incident data. Types of exposure are capitalized and addressed on 
separate lines for ease of access to the information in a hurried 
state. The company's toll-free number is provided for consumers to seek 
more information about appropriate use and first-aid.
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    \26\ OSHA Occupational Chemical Database for Methylene Chloride: 
https://www.osha.gov/chemicaldata/chemResult.html?recNo=572, 
accessed on December 8, 2017.
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VI. Implementation of This Guidance

    In this update of the 1987 Statement, the Commission provides 
guidance to industry on determining the appropriate cautionary labeling 
for paint-stripping products that contain DCM. This guidance also 
provides examples of statements to convey the hazards associated with 
the product. This guidance does not set forth language for particular 
products; nor does it specify placement of this language. However, this 
document does provide guidance on the factors to consider in developing 
the cautionary statements, and it gives examples that satisfy the FHSA. 
The level of hazard varies, based on the formulation of the product, 
the concentration of DCM, and the customary and reasonably foreseeable 
use of the product. If a paint stripper containing methylene chloride 
does not appear to be labeled appropriately, Commission staff will 
provide guidance to firms and assist firms with labeling their 
products.
    Under the FHSA, manufacturers are responsible for determining 
whether their methylene chloride-containing products meet the 
definition of a ``hazardous substance,'' and bear the appropriate 
cautionary statements. This determination is based on the concentration 
of methylene chloride, the use of the product, and whether the product 
presents a significant exposure to methylene chloride vapor with 
customary and reasonably foreseeable use. This update of the 1987 
Statement provides guidance to manufacturers who must determine the 
appropriate labeling for their paint stripper products that contain 
methylene chloride. In any enforcement action, Commission staff would 
consider on a case-by-case basis

[[Page 12259]]

whether the product's labeling meets the requirements of the FHSA.

VII. Effect on State and Local Laws

    In general, the preemption language in section 18(b)(1)(A) of the 
FHSA provides that if a hazardous substance or its packaging is subject 
to a cautionary labeling requirement under the FHSA designed to protect 
against a risk of illness or injury associated with the substance, no 
State or political subdivision of a State may establish or continue in 
effect a cautionary labeling requirement applicable to a hazardous 
substance or packaging that is designed to protect against the same 
risk of illness or injury, unless the cautionary labeling requirement 
is identical to the labeling requirement under the FHSA. 15 U.S.C. 
1261n. As mentioned, this document provides guidance to industry. This 
guidance does not have binding legal force, does not constitute a rule, 
and thus, does not have preemptive effect. However, the underlying duty 
to label a hazardous household product arises from the FHSA. This 
underlying statutory obligation preempts state and local non-identical 
cautionary labeling requirements that are designed to protect against 
the same risk of injury or illness.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2018-05580 Filed 3-20-18; 8:45 am]
BILLING CODE 6355-01-P