• Component Description
• Eligible Sample
• Description of Laboratory Methodology
• Laboratory Method Files
• Laboratory Quality Assurance and Monitoring
• Data Processing and Editing
• Analytic Notes
• References
• Codebook
  • SEQN - Respondent sequence number
  • WTSB2YR - Subsample B weights
  • URXBP3 - Urinary Benzophenone-3 (ng/mL)
  • URDBP3LC - Urinary Benzophenone-3 Comment Code
  • URXBPH - Urinary Bisphenol A (ng/mL)
  • URDBPHLC - Urinary Bisphenol A Comment Code
  • URXBPF - Urinary Bisphenol F (ng/mL)
  • URDBPFLC - Urinary Bisphenol F Comment Code
  • URXBPS - Urinary Bisphenol S (ng/mL)
  • URDBPSLC - Urinary Bisphenol S Comment Code
  • URXTLC - Urinary Triclocarban (ng/mL)
  • URDTLCLC - Urinary Triclocarban Comment Code
  • URXTRS - Urinary Triclosan (ng/mL)
  • URDTRSLC - Urinary Triclosan Comment Code
  • URXBUP - Butyl paraben (ng/mL)
  • URDBUPLC - Butyl paraben Comment Code
  • URXEPB - Ethyl paraben (ng/mL)
  • URDEPBLC - Ethyl paraben Comment Code
  • URXMPB - Methyl paraben (ng/mL)
  • URDMPBLC - Methyl paraben Comment Code
  • URXPPB - Propyl paraben (ng/mL)
  • URDPPBLC - Propyl paraben Comment Code
  • URX14D - 2,5-dichlorophenol (ng/mL)
  • URD14DLC - 2,5-dichlorophenol Comment Code
  • URXDCB - 2,4-dichlorophenol (ng/mL)
  • URDDCBLC - 2,4-dichlorophenol Comment Code

National Health and Nutrition Examination Survey

2015-2016 Data Documentation, Codebook, and Frequencies

Personal Care and Consumer Product Chemicals and Metabolites (EPHPP_I)

Data File: EPHPP_I.xpt

First Published: January 2019

Last Revised: NA

Component Description

Biomonitoring of environmental phenols, parabens, and triclocarban is used to assess prevalence and relevance of exposure in public health. The routes of human exposure to these compounds include industrial pollution, pesticide use, food consumption, and use of personal care products.

Bisphenol A (BPA) is used in the manufacture of polycarbonate plastics and epoxy resins, which can be used in protective coatings on food containers and as composites and sealants in dentistry. Concerns over potential health risks of BPA have led to restrictions on the use of BPA in certain baby and children products (U.S. Food and Drug Administration 2014). BPA alternatives, such as bisphenol S (BPS, 4,4'-sulfonyldiphenol) and bisphenol F (BPF, 4,4′-dihydroxydiphenylmethane), have been introduced in the market to replace BPA (Liao et al. 2012). Some phenols are used as sunscreen agents for skin protection, and as UV filters in cosmetic products and plastics to improve stability (e.g., benzophenone-3). Phenols are also used as bactericides (e.g., triclosan) in soap and are found in other personal care products. Other chlorophenols have been used in the wood preservation industry as intermediates in the production of pesticides, and as disinfectants or fungicides for industrial and indoor home use. The manufacture of certain chlorinated aromatic compounds can also produce chlorophenols as byproducts.

Parabens, a group of alkyl (e.g., methyl, ethyl, propyl, butyl) esters of p-hydroxybenzoic acid, are widely used as antimicrobial preservatives in personal care products, and can also be used in pharmaceuticals, as well as in food and beverage processing.

Triclocarban and triclosan have been used as an antimicrobial agent in consumer and personal care products, as well as in cleansing preparations in hospitals and other medical settings. Their uses for consumer soap, however, have been banned by FDA (the ban went into effect in 2017).

Eligible Sample

Examined participants aged 3 years and older from a one-third sample were eligible.

Description of Laboratory Methodology

A sensitive method for measuring BPA, benzophenone-3, triclosan, four parabens, two dichlorophenols, and triclocarban was developed based on a previously published approach (Zhou et al, 2014). The method uses on-line solid phase extraction coupled to high performance liquid chromatography and tandem mass spectrometry. With the use of isotopically labeled internal standards, the detection limits in 100 μL of urine are 0.1 – 1.7 micrograms per liter (μg/L), sufficient for measuring urinary levels of phenols, parabens, and triclocarban in non-occupationally exposed subjects.

Refer to the Laboratory Method Files section for a detailed description of the laboratory methods used.

There were no changes to the lab method, lab equipment, or lab site for this component in the NHANES 2015-2016 cycle.

Laboratory Method Files

Personal Care and Consumer Product (January 2019)

Laboratory Quality Assurance and Monitoring

Urine specimens are processed, stored, and shipped to the Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA for analysis.

Detailed specimen collection and processing instructions are discussed in the NHANES Laboratory Procedures Manual (LPM). Vials are stored under appropriate frozen (20°C) conditions until they are shipped to National Center for Environmental Health for testing.

The NHANES quality assurance and quality control (QA/QC) protocols meet the 1988 Clinical Laboratory Improvement Act mandates. Detailed QA/QC instructions are discussed in the NHANES LPM.

Mobile Examination Centers (MECs)

Laboratory team performance is monitored using several techniques. NCHS and contract consultants use a structured competency assessment evaluation during visits to evaluate both the quality of the laboratory work and the quality-control procedures. Each laboratory staff member is observed for equipment operation, specimen collection and preparation; testing procedures and constructive feedback are given to each staff member. Formal retraining sessions are conducted annually to ensure that required skill levels were maintained.

Analytical Laboratories

NHANES uses several methods to monitor the quality of the analyses performed by the contract laboratories. In the MEC, these methods include performing blind split samples collected on “dry run” sessions. In addition, contract laboratories randomly perform repeat testing on 2% of all specimens.

NCHS developed and distributed a quality control protocol for all CDC and contract laboratories, which outlined the Westgard rules (Westgard et al, 1981) used when running NHANES specimens. Progress reports containing any problems encountered during shipping or receipt of specimens, summary statistics for each control pool, QC graphs, instrument calibration, reagents, and any special considerations are submitted to NCHS. The reports are reviewed for trends or shifts in the data. The laboratories are required to explain any identified areas of concern.

All QC procedures recommended by the manufacturers were followed. Reported results for all assays meet the Division of Laboratory Sciences’ quality control and quality assurance performance criteria for accuracy and precision, similar to the Westgard rules (Caudill et al, 2008).

Data Processing and Editing

The data were reviewed. Incomplete data or improbable values were sent to the performing laboratory for confirmation.

Analytic Notes

Refer to the 2015-2016 Laboratory Data Overview for general information on NHANES laboratory data.

Subsample weights

Urinary environmental phenols, parabens and triclocarban were measured in a full sample of participants ages 3-5 and a one-third subsample of participants 6 years and older. Special sample weights are required to analyze these data properly. Specific sample weights for this subsample are included in this data file and should be used when analyzing these data.

Demographic and Other Related Variables

The analysis of NHANES laboratory data must be conducted with the key survey design and basic demographic variables. The NHANES 2015-2016 Demographic Data File contains demographic data, health indicators, and other related information collected during household interviews as well as the sample design variables. The recommended procedure for variance estimation requires use of stratum and PSU variables (SDMVSTRA and SDMVPSU, respectively) in the demographic data file.

This laboratory data file can be linked to the other NHANES data files using the unique survey participant identifier (i.e., SEQN).

Starting in the 2015-2016 NHANES cycle, the variable URXUCR (urine creatinine) will not be reported in this file. URXUCR can be found in the data file titled “Albumin & Creatinine – Urine”.

Detection Limits

The detection limits were constant for all of the analytes in the data set. Two variables are provided for each of these analytes. The variable name ending in “LC” (ex., URDBPHLC) indicates whether the result was below the limit of detection: the value “0” means that the result was at or above the limit of detection, “1” indicates that the result was below the limit of detection. For analytes with analytic results below the lower limit of detection (ex., URDBPHLC=1), an imputed fill value was placed in the analyte results field. This value is the lower limit of detection divided by square root of 2 (LLOD/sqrt[2]). The other variable prefixed URX (ex., URXBPH) provides the analytic result for that analyte.

The lower limits of detection (LLOD, in ng/mL) for the environmental phenols, parabens, and triclocarban:

Please refer to the NHANES Analytic Guidelines and the on-line NHANES Tutorial for further details on the use of sample weights and other analytic issues.

References

• Caudill SP, Schleicher RL, Pirkle JL. Multi-rule quality control for the age-related eye disease study. Statist Med 2008;27:4094-4106.
• Liao CY, Liu F, Moon HB, Yamashita N, Yun SH, Kannan K. 2012. Bisphenol Analogues in Sediments from Industrialized Areas in the United States, Japan, and Korea: Spatial and Temporal Distributions. Environ Sci Technol 46: 11558-11565.
• U.S. Food and Drug Administration. 2014. Bisphenol A (BPA): Use in Food Contact Application. In: U.S. Food and Drug Administration.
• Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem. 1981 Mar;27(3):493-501.
• Zhou X, Ye X, Calafat AM. Automated on-line column-switching HPLC-MS/MS method for the quantification of triclocarban and its oxidative metabolites in human urine and serum. J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Jan; 881-882:27-33.

Codebook and Frequencies