Consumer Product Safety Commission.
Notice of data availability and request for comment.
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.
The Commission must receive any comments in response to this notice by May 11, 2001.
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 firstname.lastname@example.org. Comments should be captioned “Notice of Additional Hydrocarbon Data.”Start Further Info
FOR FURTHER INFORMATION CONTACT:
Suzanne Barone, Directorate for Health Sciences, Consumer Product Safety Commission, Washington, DC 20207; telephone (301) 504-0477, ext. 1196.End Further Info End Preamble Start Supplemental Information
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. The staff recommended, and the Commission approved, the purchase of additional information from the Start Printed Page 18739AAPCC 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.
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.
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° 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 Start Printed Page 18740site at: http://www.cpsc.gov/library/foia/foia01/brief/hydrocar.pdf.Start Signature
Dated: April 6, 2001.
Todd A. Stevenson,
Acting Secretary, Consumer Product Safety Commission.
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.)Back to Citation
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.”Back to Citation
[FR Doc. 01-8955 Filed 4-10-01; 8:45 am]
BILLING CODE 6355-01-P