[Federal Register Volume 62, Number 38 (Wednesday, February 26, 1997)]
[Proposed Rules]
[Pages 8659-8663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4783]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Household Products Containing Petroleum Distillates and Other 
Hydrocarbons; Advance Notice of Proposed Rulemaking; Request for 
Comments and Information

AGENCY: Consumer Product Safety Commission.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Commission (``CPSC'' or 
``Commission'') has reason to believe that child-resistant packaging 
may be needed to protect children from serious illness or injury from 
products that contain either petroleum distillates or other 
hydrocarbons or combinations of these ingredients. This advance notice 
of proposed rulemaking (``ANPR'') initiates a rulemaking proceeding 
under the Poison Prevention Packaging Act (``PPPA''). Existing PPPA 
standards require child-resistant packaging for some products that 
contain petroleum distillates or other hydrocarbons. The Commission 
desires information on a variety of issues concerning products 
containing petroleum distillates or other hydrocarbons as it considers 
the possibility of requiring child-resistant packaging for additional 
consumer products that contain these substances.
    The Commission solicits written comments from interested persons 
concerning the risks of injury or illness associated with household 
products containing petroleum distillates and other hydrocarbons, the 
regulatory alternatives discussed in this notice, other possible means 
to address these risks, and the economic impacts of the various 
regulatory alternatives.

DATES: Written comments and submissions in response to this notice must 
be received by the Commission by May 12, 1997.

ADDRESSES: Comments should be mailed, preferably in five copies, to the 
Office of the Secretary, Consumer Product Safety Commission, 
Washington, DC 20207-0001, or delivered to the Office of the Secretary, 
Consumer Product Safety Commission, Room 502, 4330 East-West Highway, 
Bethesda, Maryland 20814; telephone (301) 504-0800. Comments should be 
captioned ``ANPR for Petroleum Distillates.''

FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Directorate for 
Epidemiology and Health Sciences, Consumer Product Safety Commission, 
Washington, DC 20207; telephone (301) 504-0477, ext. 1196.

SUPPLEMENTARY INFORMATION:

I. Background

    1. Introduction. Petroleum distillates are a group of hydrocarbon-
based chemicals that are refined from crude oil. Petroleum distillates 
include gasoline, naphtha, mineral spirits, kerosene, paraffin wax, and 
tar. They are the primary ingredient in many consumer products, 
including certain furniture polishes, paint solvents, adhesives, and 
automotive chemicals. As explained below, the presence of such 
petroleum distillates in products may contribute to the products' 
toxicity.
    A number of consumer products contain hydrocarbons that are not 
petroleum distillates, but that can cause similar toxic effects. These 
other hydrocarbons include substances such as benzene, toluene, xylene, 
pine oil, turpentine, and limonene.

[[Page 8660]]

    The toxicity of petroleum distillates and other hydrocarbons 
affects the respiratory system. Aspiration of small amounts of these 
chemicals directly into the lung, or into the lung during vomiting of 
an ingested chemical, can cause chemical pneumonia, pulmonary damage, 
and death. Petroleum distillates with low viscosity, such as gasoline, 
kerosene, and mineral seal oil, possess the greatest potential for 
aspiration.1
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    \1\ Liquids with high viscosity are thick and more like syrup, 
while liquids with low viscosities are thin and more watery. See 
Table 1.
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    As explained below, all household products that contain 10 percent 
or more of petroleum distillates, or of benzene, toluene, xylene, or 
turpentine, are required to have hazard warnings by regulations under 
the Federal Hazardous Substances Act (``FHSA''). Some other products 
that contain hydrocarbons may be required to be labeled by more general 
FHSA requirements. Some, but not all, of these products are also 
required to be in child-resistant packaging under PPPA regulations.
    The purpose of this notice is to commence a rulemaking proceeding 
to examine whether additional products containing petroleum distillates 
or other hydrocarbons should be in child-resistant packaging.2
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    \2\ The Commission voted 2-1 to approve publication of this 
ANPR. Voting to approve were Chairman Ann Brown and Commissioner 
Thomas Moore. Commissioner Mary Sheila Gall voted to develop a 
Request for Information for publication in the Federal Register and 
to utilize other available information sources instead of an ANPR. 
Commissioner Gall also issued a statement concerning this vote. The 
statement is available from the Office of the Secretary.
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II. The Possible Need for Additional Regulation

     1. Poisoning information. The Commission evaluated pediatric 
poisoning cases associated with product classes that are known to 
include products that contain hydrocarbons, and that are not currently 
required to be in child-resistant packaging. Such product areas include 
adhesives, automotive chemicals, workshop chemicals, metal polishes, 
spot removers, cleaning fluids, shoe polishes, and lubricants. The CPSC 
staff reviewed data from various sources, including the National 
Electronic Injury Surveillance System (``NEISS''), and the American 
Association of Poison Control Centers' (``AAPCC'') Toxic Exposure 
Surveillance System (``TESS'').
    According to NEISS, between 1990 and 1994 there was an annual 
estimated average of about 2,300 emergency room visits of children 
under 5 years of age associated with exposure to product categories 
that are not required to be in child-resistant packaging and that 
include products containing petroleum distillates. About 5 percent of 
these cases resulted in hospitalization.
    Between October 1994 and May 1996, a CPSC contractor conducted 
telephone investigations on incidents reported through NEISS that were 
treated in hospital emergency rooms and involved children under 5 years 
of age who had been exposed to products in the categories described 
above. The telephone investigations produced 43 cases for analysis. Of 
these, 18 involved petroleum distillates and 25 involved products 
containing the hydrocarbon pine oil. Most of the incidents occurred in 
the child's home. About 50 percent of the victims accessed the product 
from its normal storage area rather than from another location. 
Seventy-nine percent of the incidents involved products in the original 
packaging. Most of these containers were reported to be non-child-
resistant.
    In 1994, the Poison Control Centers (``PCC's) reported 5,791 
exposures of children under 5 years of age that were attributed to 
product categories that included only products that contain petroleum 
distillates or other hydrocarbons. Of these, 1130 cases reported 
symptoms, most of which were minor (exhibited some symptoms that were 
minimally bothersome to the patient, i.e. the symptoms usually resolved 
rapidly and usually involved skin or mucous membranes). Ninety-three of 
these cases reported moderate outcomes (exhibited symptoms that were 
more pronounced, more prolonged, or of more of a systemic nature than 
minor symptoms). In addition, 7 cases reported major symptoms (life-
threatening or resulted in significant residual disability or 
disfigurement). A number of other PCC product categories may also 
include products that contain petroleum distillates or other 
hydrocarbons.
    The Commission is aware of 10 reported deaths since 1973 of 
children under 5 following exposure to products that contained 
petroleum distillates and for which child-resistant packaging is not 
currently required. Six of these reports indicated that the deaths were 
caused by chemical pneumonitis or aspiration.
    The death and injury data discussed above suggest that the safety 
of young children could be improved if additional products that contain 
petroleum distillates and other hydrocarbons are required to be 
packaged in child-resistant packaging.
    2. Existing regulatory requirements.
    a. Applicable requirements under the Federal Hazardous Substances 
Act (``FHSA''). The CPSC regulates the labeling of hazardous household 
products under the FHSA, 15 U.S.C. 1261-1278. Currently, FHSA 
regulations require specified aspiration hazard labeling for products 
containing 10 percent or more by weight of benzene, toluene, xylene, or 
petroleum distillates such as kerosene, mineral seal oil, naphtha, 
gasoline, mineral spirits, Stoddard solvent, and ``related'' 
distillates. 16 CFR 1500.14(a)(3), (b)(3). The label must bear the 
signal word ``DANGER,'' the statement of hazard ``Harmful or fatal if 
swallowed,'' and the statement ``Call physician immediately.'' 16 CFR 
1500.14(b)(3). A similar labeling requirement applies to products 
containing 10 percent or more of turpentine because of the aspiration 
hazard. See 16 CFR 1500.14(b)(5).

[[Page 8661]]

    In addition, section 2(p)(1) of the FHSA requires any household 
product that is ``toxic'' to bear specified hazard labeling. 15 U.S.C. 
1261(p)(1). Any product that presents an aspiration risk from 
hydrocarbons is required to bear the labeling specified by section 
2(p)(1), regardless of whether a regulation specifically applies to 
that product.
    b. Applicable requirements under the Poison Prevention Packaging 
Act (``PPPA''). The CPSC also regulates the packaging of many household 
products containing petroleum distillates or other hydrocarbons under 
the PPPA, 15 U.S.C. 1471-1476. PPPA regulations require that products 
be sold in child-resistant packaging.
    Currently, some consumer products containing 10 percent or more by 
weight of petroleum distillates, and with a viscosity less than 100 
Saybolt Universal Seconds (``SUS'') at 100 deg.F, are subject to the 
PPPA's child-resistant packaging standards. 3 The particular types 
of petroleum distillate products that require child-resistant packaging 
under the PPPA include (1) prepackaged liquid kindling and illuminating 
preparations (e.g., lighter fluid) (16 CFR 1700.14(a)(7)), (2) 
prepackaged solvents for paint or other similar surface-coating 
materials (e.g., varnishes)(16 CFR 1700.14(a)(15)), and (3) nonemulsion 
liquid furniture polish (16 CFR 1700.14(a)(2)). Child-resistant 
packaging is also required for certain solvents containing 10 percent 
or more of benzene, toluene, or benzene, and with a viscosity less than 
100 SUS at 100 deg.F. 16 CFR 1700.14(a)(15). In addition, products 
containing 10 percent or more of turpentine are required to be in 
child-resistant packaging. 16 CFR 1700.14(a)(6).
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    \3\  Saybolt Universal Seconds is a measure of viscosity. The 
higher the SUS, the more viscous the liquid.
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    c. Varying scope of the FHSA and PPPA regulations. While FHSA 
labeling regulations apply generically to products that contain 10 
percent or more petroleum distillates or other hydrocarbons, only 
certain specified products are required to be in child-resistant 
packaging under the current PPPA regulations. Therefore, a number of 
household products containing petroleum distillates or other 
hydrocarbons are not required to be in child-resistant packaging. For 
example, cleaning solvents, automotive chemicals, shoe care products, 
and floor care products may contain large amounts of various petroleum 
distillates. These products are not required to be sold in child-
resistant packaging, but some of them are required to be labeled under 
the FHSA. See 16 CFR 1500.14(a)(3), (b)(3).
    In addition, there are some anomalies under the current PPPA 
regulations concerning which products are required to be in child-
resistant packaging. For example, the existing standards require child-
resistant packaging of prepackaged kerosene for use as lamp fuel. 16 
CFR 1700.14(a)(7). However, a gun cleaning solvent that contains over 
90 percent kerosene does not have this requirement. Mineral spirits 
used as a paint solvent require child-resistant packaging, 16 CFR 
1700.14(a)(15), but such packaging is not required for spot removers 
containing 75 percent mineral spirits or water repellents containing 95 
percent mineral spirits. Yet, all of these consumer products are 
required by the FHSA to be labeled ``Harmful or fatal if swallowed.'' 
16 CFR 1500.14(b)(3).
    A rule to require child-resistant packaging of all household 
products that contain petroleum distillates and have specified 
characteristics would create a more consistent regulatory approach and 
afford greater protection against poisonings.

III. Issues to be Considered During the Rulemaking

    During this rulemaking, the Commission will consider the following 
major issues.
    1. Viscosity and percentage composition. As noted above, the PPPA's 
child-resistant packaging standards currently apply to certain 
specified consumer products containing 10 percent or more by weight of 
petroleum distillates, and with a viscosity less than 100 SUS at 100 
deg.F. Products associated with chemical pneumonia and death have had 
viscosities below this level. Again, liquids with low viscosities are 
more likely to be aspirated than more syrup-like liquids with high 
viscosities.
    The Commission's staff collected a limited number of household 
products that contain petroleum distillates and measured their 
viscosities. The results are listed in Table 1.

 Table 1.--The Viscosities of Products Containing Petroleum Distillates 
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                                          PPPA                          
                                        Regulated   Viscosity (SUS @100 
               Product                   (yes or         deg.F) \4\     
                                           no)                          
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Motor oil (10W-30)...................          N   325       
Heavy Mineral Oil....................          N   180                  
Baby Oil.............................          N   70        
Furniture Polish.....................          Y   40        
Gasoline Treatment...................          N   35        
Carburetor Cleaner...................          N   <32 \5\              
Degreaser............................          N   <32 \4\              
 Lighter Fluid.......................          Y   <32 \4\              
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\4\ The staff measured the viscosity at 100  deg.F using a Brookfield   
  viscometer calibrated in centistokes (cs). The value was converted to 
  SUS using Table 1 of ASTM D 2161-93, Standard Practice for Conversion 
  of Kinematic Viscosity to Saybolt Universal Viscosity or to Saybolt   
  Furol Viscosity.                                                      
\5\ There are no equivalent viscosities measured in SUS for viscosities 
  less than 1.8 cs. The viscosity of 1.83 cs is equivalent to 32 SUS.   

    The staff's initial laboratory analysis, summarized in Table 1, 
shows that lighter weight oils, including some baby oils, would be 
included in a regulation that required child-resistant packaging of all 
products containing at least 10 percent petroleum distillates with a 
viscosity less than 100 SUS at 100  deg.F.

[[Page 8662]]

There are reported cases of lipoid pneumonia and deaths from aspiration 
of lubricants, including baby oil, a spray lubricant, chain saw oil, 
and trumpet valve oil.6
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    \6\ Reyes De La Rocha, S. et al. Lipoid pneumonia secondary to 
baby oil aspiration: a case report and review of the literature. 
Pediatric Emergency Care, 1:74, 1985.
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    The Commission will consider whether a viscosity criterion should 
be included in any regulation requiring child-resistant packaging for 
products containing petroleum distillates or other hydrocarbons. If 
such a criterion is to be included, the Commission will also consider 
at what level it should be set.
    2. Other hydrocarbons. The CPSC's FHSA regulations for petroleum 
distillates require labeling of some products containing other 
hydrocarbons, including products that contain 10 percent or more by 
weight of benzene, toluene, or xylene. 16 CFR 1500.14(a)(3), (b)(3). 
FHSA labeling is required because these substances have an aspiration 
hazard similar to petroleum distillates.
    A number of household products contain low-viscosity hydrocarbons 
other than petroleum distillates. These hydrocarbons include benzene, 
toluene, xylene, and terpenes. For example, terpene hydrocarbons 
derived from wood or fruit are in products such as turpentine, pine 
oil, and limonene. Pine oil and limonene are found in cleaning products 
and spot removers, as well as disinfectants. (Products marketed as 
disinfectants are not regulated by the CPSC; they are regulated as 
pesticides by the Environmental Protection Agency (``EPA'').) Although 
pine oil and limonene cleaning products and spot removers require FHSA 
labeling, they are not currently required to be in child-resistant 
packaging.
    The Commission will consider whether there is a need for a special 
packaging standard applicable to products containing hydrocarbons other 
than petroleum distillates.
    3. Aerosols. The PPPA regulation for furniture polish excludes 
products in aerosol form. The rationale for excluding aerosol furniture 
polishes was that aerosols would be addressed separately. 36 FR 18012 
(September 8, 1971). However, there has been no further regulatory 
action on aerosol furniture polishes.
    The child-resistant packaging requirements for paint solvents and 
kindling and illuminating preparations do not specifically exempt 
aerosol products. See 16 CFR 1700.14(a)(7), (a)(15). However, the 
Commission is not aware of any paint solvent or liquid kindling or 
illuminating fluid sold in an aerosol form.
    CPSC exposure data on aerosol products are limited.7 
Inhalation of a spray lubricant has been associated with lipoid 
pneumonia.8 The NEISS case investigation study, described above, 
identified 4 percent of the cases as involving products in aerosol 
form. However, none of the people in these aerosol cases was 
hospitalized.
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    \7\ Nierenberg, D.W., et al. Mineral Spirits Inhalation 
Associated with Hemolysis, Pulmonary Edema, and Ventricular 
Fibrillation. Arch Intern Med, 151:14337, 1991. Rodriguez de la 
Vega, A. et al. Kerosene-induced Asthma. Annals of Allergy, 64:362, 
1990. Glynn, K.P. and Gale, N., Exogenous Lipoid Pneumonia due to 
Inhalation of Spray Lubricant, Chest, 97:1265, 1990.
    \8\ Id. (Glynn, 1990).
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    The cases described in the medical literature that resulted from 
the inhalation of petroleum distillates from aerosols or vapors 
involved prolonged or repeated exposure of adults. However, children 
are subject to greater inhalation risks than are adults, for equal 
exposure levels.9
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    \9\ Schiller-Scotland, C.F, et al. Experimental data for total 
disposition in the respiratory tract of children. Toxicol. Lett., 
72: 137, 1994.
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    The Commission will consider whether aerosol products should be 
included within any regulation applicable to products containing 
petroleum distillates and other hydrocarbons.
    4. Restricted flow. The PPPA regulation for liquid furniture polish 
includes an additional requirement that no more than 2 milliliters of 
product shall be obtained when the container is shaken, squeezed, or 
activated once. 16 CFR 1700.14(a)(2). This requirement was included, in 
part, because an open container of polish may be moved and used 
multiple times throughout the house before the container is closed. 37 
FR 5613 (March 17, 1972). Furniture polish is the only PPPA-regulated 
substance with a restricted-flow requirement.
    The Commission will consider whether other products should be 
subject to a restricted flow requirement.

IV. Rulemaking Procedure

    In order to issue a regulation under the PPPA, the Commission would 
have to find that ``the degree or nature of the hazard to children in 
the availability of (petroleum distillates and other hydrocarbons), by 
reason of (their) packaging, is such that special packaging is required 
to protect children from serious personal injury or serious illness 
resulting from handling, using, or ingesting such substance.'' 15 
U.S.C. 1472(a)(1). The Commission would also have to find that child-
resistant packaging ``is technically feasible, practicable, and 
appropriate'' for products containing petroleum distillates or other 
hydrocarbons. 15 U.S.C. 1472(a)(2).
    According to the PPPA's legislative history, ``technically 
feasible'' means that technology exists to produce packaging that 
conforms to the standards.10 ``Practicable'' means that special 
packaging complying with the standards can utilize modern mass 
production and assembly line techniques.11 ``Appropriate'' means 
that packaging complying with the standards will adequately protect the 
integrity of the substance and not interfere with its intended storage 
or use.12
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    \10\ S. Rep. 845, 91st Cong., 2d Sess. 10 (1970).
    \11\ Id.
    \12\ Id.
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    In addition to the required findings, the Commission is required to 
consider, but not necessarily make formal findings on, (a) the 
reasonableness of the standard, (b) available scientific, medical, and 
engineering data concerning special packaging and concerning childhood 
accidental ingestions, illness, and injury caused by household 
substances, (c) the manufacturing practices of industries affected by 
the PPPA, and (d) the nature and use of the household substance. 15 
U.S.C. 1472(b).
    A rulemaking proceeding under the PPPA is subject to the 
requirements of the Administrative Procedure Act. Therefore, the 
proceeding can be commenced by publication of a notice of proposed 
rulemaking (``NPR''), without having previously published an ANPR. 
However, in this proceeding, the Commission is publishing an ANPR in 
order to obtain additional information before deciding whether to 
propose a special packaging standard for products that contain 
petroleum distillates or other hydrocarbons.

V. Comments Requested Concerning the Scope of a Rule

    The Commission is seeking information on issues relevant to 
defining the scope of any child-resistant packaging requirement for 
products containing low-viscosity petroleum distillates and other 
hydrocarbons. These issues include the following:
    1. What, if any, viscosity and/or percentage composition should be 
used as a threshold for requiring products that contain petroleum 
distillates to be in child-resistant packaging?
    2. Should aerosol products be included in a requirement for the 
child-resistant packaging of products containing petroleum distillates 
or other

[[Page 8663]]

hydrocarbons? The Commission seeks information on the possible effects 
to a young child of a single acute exposure to an aerosol product 
containing petroleum distillates.
    3. Should PPPA regulation extend only to petroleum distillates or 
should such regulation also extend to other hydrocarbons, such as 
benzene, toluene, xylene, turpentine, pine oil, and limonene?
    4. Should restricted flow be an additional requirement for certain 
products?

VI. Additional Requests for Information

    The Commission believes that information on the following issues 
would also be helpful as it considers whether child-resistant packaging 
should be required for the entire class of consumer products that 
present an aspiration hazard because they contain petroleum distillates 
or other hydrocarbons.
    1. Chemical properties. Information concerning the chemical 
properties of individual consumer products that contain petroleum 
distillates or other hydrocarbons will be used to compare products that 
do not currently require child-resistant packaging with those that do. 
The Commission requests information about the form (e.g., liquid or 
aerosol), formulation (including the amount of each component), and 
viscosity of each product.
    2. Users and use patterns. The Commission would like information 
about consumer use patterns for various types of products containing 
petroleum distillates or other hydrocarbons. The Commission requests 
information concerning: The intended use of the product (e.g., as a 
shoe waterproofer, carpet cleaner, upholstery spot remover); the 
location(s) where it is used (e.g., in a garage, a kitchen, a 
bathroom); the frequency of use (e.g., daily, monthly, seasonally); how 
long a package of the product is retained in the home (e.g., used just 
once or stored for long periods between uses); and the location(s) 
where it is stored when not in use. In addition, is the product used by 
consumers (more than occasionally) or is the product only used in the 
home by workers, such as repair or cleaning persons?
    3. Current packaging and labeling. Information about the packaging 
of products that contain petroleum distillates will be used to assess 
the technical feasibility, practicability, and appropriateness of 
child-resistant packaging. The Commission requests information 
describing current packaging, such as packaging sizes, container 
material, closure material, closure design, and ASTM classification if 
the package is child-resistant. Information is also requested about 
whether the product has labels with warnings and instructions for use.
    4. Economic information. Economic information will be used to 
evaluate the impact of requiring child-resistant packaging for all 
products containing petroleum distillates or other hydrocarbons. The 
Commission requests information about sales of these products and about 
the range of wholesale and retail prices. Further, the Commission seeks 
comments on the expected cost of providing child-resistant packaging 
for these products. In addition, the Commission requests information 
about the potential impact that such child-resistant packaging 
requirements would have on businesses, especially small businesses.
    5. Incident information. Although the Commission monitors data on 
ingestions by young children of products that contain petroleum 
distillates and other hydrocarbons, the Commission seeks additional 
information about such poisoning incidents. This information will be 
used to assess the extent of injury from different product 
formulations. The Commission requests information concerning the 
details of scenarios resulting in poisoning incidents, and the outcome 
of the incident.
    Comments should be mailed, preferably in five copies, to the Office 
of the Secretary, Consumer Product Safety Commission, Washington, DC 
20207-0001, or delivered to the Office of the Secretary, Consumer 
Product Safety Commission, Room 502, 4330 East-West Highway, Bethesda, 
Maryland 20814; telephone (301) 504-0800. All comments and submissions 
should be received no later than May 12, 1997.

VII. Trade Secret or Proprietary Information

    Any person responding to this notice who believes that any 
information submitted is trade secret or proprietary should identify 
all such information at the time of submission. The Commission's staff 
will receive and handle such information confidentially and in 
accordance with section 6(a) of the Consumer Product Safety Act 
(``CPSA''), 15 U.S.C. 2055(a). Such information will not be placed in a 
public file and will not be made available to the public simply upon 
request. If the Commission receives a request for disclosure of the 
information or concludes that its disclosure is necessary to discharge 
the Commission's responsibilities, the Commission will inform the 
person who submitted the information and provide that person an 
opportunity to present additional information and views concerning the 
confidential nature of the information. 16 CFR 1015.18(b).
    The Commission's staff will then make a determination of whether 
the information is trade secret or proprietary information that cannot 
be released. That determination will be made in accordance with 
applicable provisions of the CPSA; the Freedom of Information Act 
(``FOIA''), 5 U.S.C. 552b; 18 U.S.C 1905; the Commission's procedural 
regulations at 16 CFR part 1015 governing protection and disclosure of 
information under provisions of FOIA; and relevant judicial 
interpretations. If any part of information that has been submitted 
with a claim that the information is a trade secret or proprietary is 
found to be disclosable, the person submitting the material will be 
notified in writing and given at least 10 calendar days from the 
receipt of the letter to seek judicial relief. 15 U.S.C. 2055(a) (5) 
and (6); 16 CFR 1015.19(b).

    Dated: February 21, 1997.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 97-4783 Filed 2-25-97; 8:45 am]
BILLING CODE 6355-01-P