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Notice of Availability: Estimated Phthalate Exposure and Risk to Women of Reproductive Age as Assessed Using 2013/2014 NHANES Biomonitoring Data

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U.S. Consumer Product Safety Commission.


Notice of availability.


The Consumer Product Safety Commission (Commission, or CPSC) is announcing the availability of a document titled, “Estimated Phthalate Exposure and Risk to Women of Reproductive Age as Assessed Using 2013/2014 NHANES Biomonitoring Data.”


Submit comments by March 24, 2017.


You may submit comments, identified by Docket No. CPSC-2014-0033, by any of the following methods:

Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

Written Submissions: Submit written submissions by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

Instructions: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing.

Docket: For access to the docket to read background documents or comments received, go to:, and insert the docket number CPSC-2014-0033, into the “Search” box, and follow the prompts.

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Kent R. Carlson, Ph.D., Toxicologist, Division of Toxicology & Risk Assessment, Directorate for Health Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850-3213; email:

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Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) required the Commission to appoint a Chronic Hazard Advisory Panel (CHAP) to study the effects on children's health of phthalates and phthalate alternatives in children's toys and child care articles. Public Law 110-314, Section 108(b)(2)(A). The CHAP report is available at:​PageFiles/​169902/​CHAP-REPORT-With-Appendices.pdf.

The CPSIA also required that the CHAP issue a report to the Commission and that the Commission conduct rulemaking based on the CHAP report. Id. Section 108(b)(2)(C); 108(b)(3). On December 30, 2014, the Commission issued a notice of proposed rulemaking (NPR) that would prohibit children's toys and child care articles containing specified phthalates. 79 FR 78324 (December 30, 2014).

The CHAP assessed human exposure to phthalates, in part, through human biomonitoring analysis. Among the data sources the CHAP considered were data from the National Human Health and Nutrition Survey (NHANES). See 79 FR at 78327. Specifically, the CHAP used biomonitoring data from the 2005/2006 NHANES data set.

In June 2015, CPSC staff released a document, “Estimated Phthalate Exposure and Risk to Pregnant Women and Women of Reproductive Age as Assessed Using Four NHANES Biomonitoring Data Sets (2005/2006, 2007/2008, 2009/2010, 2011/2012).” [1] The June 2015 analysis reviewed the 2005/2006 NHANES data set to replicate the CHAP's methodology and reviewed the subsequent NHANES data sets from 2007/2008, 2009/2010, 2011/2012). On June 23, 2015, the Commission published a notice of availability (NOA) in the Federal Register requesting public comment on the June 2015 staff analysis document. 80 FR 35938 (June 23, 2015).

Since the June 2015 staff analysis, the Centers for Disease Control released the NHANES 2013/14 data set. In response to the release of the NHANES 2013/14 data set, CPSC staff has prepared a document reflecting the staff's analysis of the NHANES 2013/2014 data set: “Estimated Phthalate Exposure and Risk to Women of Reproductive Age as Assessed Using 2013/2014 NHANES Biomonitoring Data.” The document is available on the Commission's Web site at:​s3fs-public/​Estimated%20Phthalate%20Exposure%20and%20Risk%20to%20Women%20of%20Reproductive%20Age%20as%20Assessed%20Using%202013%202014%20NHANES%20Biomonitoring%20Data.pdf and from the Commission's Office of the Secretary at the location listed in the ADDRESSES section of this notice.

The Commission invites comment on the document, “Estimated Phthalate Exposure and Risk to Women of Reproductive Age as Assessed Using 2013/2014 NHANES Biomonitoring Data.” Comments should be submitted by March 24, 2017. Information on how to submit comments can be found in the ADDRESSES section of this notice.

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Dated: February 16, 2017.

Todd A. Stevenson,

Secretary, Consumer Product Safety Commission.

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[FR Doc. 2017-03455 Filed 2-21-17; 8:45 am]