[Federal Register: April 11, 2001 (Volume 66, Number 70)]
[Proposed Rules]               
[Page 18738-18740]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ap01-12]                         

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR PART 1700

 
Household Products Containing Hydrocarbons; Notice of Data 
Availability and Request for Comments

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of data availability and request for comment.

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SUMMARY: In the Federal Register of January 3, 2000, the Consumer 
Product Safety Commission (``CPSC'' or ``Commission'') published a 
notice of proposed rulemaking (``NPR'') proposing child-resistant 
packaging requirements for household chemical and cosmetic products 
with viscosity less than 100 Saybolt Universal Seconds (``SUS'') 
containing 10 percent or more hydrocarbons. 65 FR 93. Since that time, 
CPSC's staff has acquired brand name-specific data on exposure to 
possible hydrocarbon-containing cosmetics and has conducted an analysis 
of that data as well as an additional analysis of the data available 
when the NPR was issued.
    This notice makes these staff analyses available for public 
comment. Today's notice does not re-open the comment period on the NPR.

DATES: The Commission must receive any comments in response to this 
notice by May 11, 2001.

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 also may 
be filed by facsimile to (301)504-0127 or by e-mail to cpsc-
os@cpsc.gov. Comments should be captioned ``Notice of Additional 
Hydrocarbon Data.''

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

SUPPLEMENTARY INFORMATION:

A. Background

    The January 3, 2000 NPR presented ingestion data collected by the 
American Association of Poison Control Centers'(``AAPCC'') Toxic 
Exposure Surveillance System (``TESS'') for general cosmetic categories 
that may contain low viscosity hydrocarbons. The categories included: 
(1) Miscellaneous nail products; (2) sunscreen and suntan preparations; 
(3) bubble bath and bath oil; and (4) creams, lotions, and make-up. The 
data presented in the NPR were from the years 1995 through 1997.
    A total of 74,042 ingestion incidents were reported in these 
product categories. While these incidents were not limited to known 
hydrocarbon-containing cosmetics, they demonstrate that children access 
the contents of these types of products in the home. Thus, if such 
products contain hydrocarbons of low viscosity, aspiration and 
therefore serious injury, can result. In addition, the NPR included 
1996-1997 AAPCC data for exposures to baby oil, a cosmetic product 
known to contain low viscosity mineral oil, which is a hydrocarbon.
    An analysis of brand name-specific cosmetic data obtained by CPSC 
staff after the NPR was issued is presented below. Data on additional 
deaths and the additional CPSC staff analysis of the data available 
when the NPR was issued are also presented.

B. Brand-Specific Cosmetic Data

    At the December 3, 1999 Commission briefing on the NPR, 
Commissioner Gall requested that the staff develop a plan for the 
collection and analysis of additional data related to ingestion 
incidents involving mineral oil-based cosmetics.\1\ The staff 
recommended, and the Commission approved, the purchase of additional 
information from the

[[Page 18739]]

AAPCC on ingestion incidents involving mineral oil-based cosmetics. 
Permission was obtained from the AAPCC Board of Directors to purchase 
brand name data for the year 1998 for four cosmetic categories. Data on 
the following product categories were purchased: (1) Miscellaneous nail 
products; (2) sunscreen and suntan preparations; (3) bubble bath and 
bath oil; and (4) creams, lotions, and make-up.
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    \1\ See Statement of Commissioner Mary Sheila Gall on 
publication of a notice of proposed rulemaking to require special 
packaging for low-viscosity hydrocarbons, December 3, 1999. See 
also, Statement of Commissioner Thomas H. Moore on the same subject. 
(Copies of these statements are available from the CPSC Office of 
the Secretary.)
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    A comment was received from the Cosmetic, Toiletry, and Fragrance 
Association (CTFA) (CP00-1-6) in response to the NPR requesting the 
opportunity to review and comment on the additional cosmetic data 
purchased from the AAPCC. These data contain brand names and must 
remain proprietary under the terms by which CPSC acquired them from the 
AAPCC. Therefore the database cannot be made available to the public. 
However, the staff analysis of the data that is summarized in this 
notice is available to the public. Copies may be obtained from the 
Office of the Secretary. The analysis is also available on the CPSC 
world wide web site at: http://www.cpsc.gov/library/foia/foia01/brief/
hydrocar.pdf.
    The supplemental AAPCC cosmetic database purchase contained a total 
of 31,903 ingestion cases coded as: (1) Miscellaneous nail products; 
(2) sunscreen and suntan preparations; (3) bubble bath or bath oil; and 
(4) creams, lotions, and make-up. Of these, 538 cases involved 
ingestion of more than one substance and were therefore eliminated from 
consideration. Of the 31,365 single substance ingestions, 476 involved 
potential aspirations as defined below by CPSC staff in Section D., 
Additional Analysis of Data Available when NPR Was Issued. Seventeen of 
the aspiration cases involved a serious medical outcome.\2\
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    \2\ ``Serious medical outcome'' is defined for purposes of this 
analysis as a TESS case with an outcome coded as ``moderate 
effect,'' ``major effect,'' death, or ``not followed up-potentially 
toxic.''
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    CPSC staff eliminated 2,049 products (22,262 exposures) from 
further consideration because either the products were known not to 
contain hydrocarbons or the formulations were emulsions or solids. Of 
the remainder, 30 products (1,461 exposures) would require child-
resistant packaging under the proposed rule. Staff lacked sufficient 
information to make that determination for 222 products (7,642 
exposures). Some of these were from a specific cosmetic product 
category such as ``bath oil,'' some members of which may require 
packaging under the rule as proposed, but were products for which a 
brand name was not available. The remaining ones were products for 
which no formulation information was available.
    The staff evaluated the combined data set of cases that were either 
known to be or might be subject to the rule as proposed. The two 
parameters evaluated were potential aspiration and serious injury. Five 
potential aspiration cases were identified in this manner as having 
serious medical outcomes. Three of these cases involved baby oil and 
two involved bath oil. There were 224 additional cases coded as 
potential aspirations that did not result in serious effects. Seventy-
nine cases resulted in serious outcomes but did not meet the staff 
criteria for potential aspiration.

C. Additional Deaths

    Seven fatalities were identified in categories of products known to 
contain hydrocarbons. Five of these deaths were not reported in the NPR 
or the preceding advance notice of proposed rulemaking (``ANPR''). 62 
FR 8,659 (February 26, 1997). Of these, three deaths were identified in 
TESS that were caused by products that appear not to be subject to the 
rule. The first case was the death of a child following ingestion and 
aspiration of a homemade cleaning product. The second case was the 
death of a child following ingestion and aspiration of motor oil. The 
third TESS case was the death of a child following ingestion and 
aspiration of hair oil. The products involved in these three deaths 
either contain less than 10 percent hydrocarbons or have a viscosity 
greater than 100 SUS at 100 deg. F.
    The other two deaths that were identified in CPSC databases were 
apparently caused by products that would be subject to the rule as 
proposed. The first death occurred in 1997 when a 12-month female died 
45 days following ingestion of baby oil. The autopsy revealed that the 
child died as a result of a left hemothorax due to complications from 
swallowing and aspirating baby oil.
    The second death occurred in 2000 when a 9-month old female died 
six days following the ingestion of a hair moisturizer product. The 
patient suffered respiratory arrest and died in the intensive care 
unit.

D. Additional Analysis of Data Available When NPR Was Issued

    Commissioner Gall's specific interest in cases involving mineral 
oil-based cosmetics also prompted a reevaluation by CPSC staff of the 
data available at the NPR stage with a focus on aspiration. The data 
presented in the NPR contained 114 cases of cosmetic exposure coded as 
aspirations by the AAPCC for the years 1995, 1996, and 1997 (29, 36, 
and 49 respectively).
    TESS codes identify the routes of exposure for poisoning cases. 
These route codes include, ``ingestion,'' ``aspiration,'' ``inhalation/
nasal,'' ``ocular,'' ``dermal,'' ``bite/sting,'' or ``parenteral.'' The 
74,042 incidents identified in the NPR were ingestions that did not 
also involve other routes of exposure. However, according to AAPCC 
coding guidelines, all cases coded as aspiration are also coded as 
ingestions.
    Upon reevaluation, the CPSC staff believed that using only 
incidents coded with the aspiration route of exposure was 
underestimating the number of aspiration incidents. Numerous cases not 
coded as aspirations resulted in respiratory effects. Therefore, in 
addition to any case coded as an aspiration by the AAPCC, any 
inhalation or nasal route of exposure case, and any ingestion case that 
also had related respiratory effects, was considered by the CPSC staff 
to be a potential aspiration. Many of these cases are not coded as 
aspiration cases by the AAPCC. For example, a case of aspiration of 
hydrocarbon following vomiting may not be coded as an aspiration by the 
AAPCC because the initial route of exposure may have been ingestion. 
However, if the child exhibits respiratory effects related to the 
poisoning, the case would be considered an ``aspiration'' for purposes 
of this analysis.
    The CPSC staff reanalyzed the TESS data originally presented in the 
NPR to take into account the additional cases of potential aspiration. 
In addition, several other changes were made. The analysis was expanded 
to include cases involving all routes of exposure. However, cases 
involving more than one product and cases where the age of the child 
was unknown were eliminated.
    Reanalysis of the TESS cosmetic data in this manner resulted in 
1200 cases of potential aspiration for the years 1995-1997 as opposed 
to the 114 cases identified in the NPR.
    The TESS cosmetic data for the years 1993 through 1999 show 186,359 
exposures with 2,894 potential aspirations. The TESS data also show 
109,823 exposures to household chemical product categories that may 
contain hydrocarbons, 8,221 of which were potential aspirations.
    The detailed staff reanalysis of these data is available to the 
public. Copies may be obtained from the Office of the Secretary. The 
reanalysis is also available on the CPSC world wide web

[[Page 18740]]

site at: http://www.cpsc.gov/library/foia/foia01/brief/hydrocar.pdf.

    Dated: April 6, 2001.
Todd A. Stevenson,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. 01-8955 Filed 4-10-01; 8:45 am]
BILLING CODE 6355-01-P